Hear What People Say

About Abbott's neurostimulation therapies

elderly couple
elderly couple
elderly couple

Be inspired by people who find relief

Explore the inspiring personal stories of people who’ve reclaimed their lives from chronic pain. Find out how spinal cord stimulation (SCS) or dorsal root ganglion (DRG) therapy can help people with chronic pain live fuller lives – and see firsthand what life is like with an implanted neurostimulator.

These are actual patient stories. The stories are the experience of these individuals only. Although these patients did not experience complications, there can be risks and potential complications associated with the use of medical devices. If you are interested in learning more, please consult your physician.

Watch the videos

“Alert to the world around me” - Jeff’s story
“Now I have my life back” - Ann’s Story
“It’s night and day” - Josh’s story
“Feeling free from pain” - Robert’s story

Read the articles

robert photo
robert photo
robert photo

Robert: From constant, severe pain to now carrying his daughter on his shoulders

"I think the saddest moment was when I realized I couldn't pick up my two-year-old daughter,” said Robert, a Marine officer and lawyer who was not accustomed to feeling vulnerable. He realized that he "could not take care of her by myself. And that's a terrifying thing as a young father.

After breaking his leg in three places, having surgery, and being deemed not physically qualified to continue with Marine Officer Training School at the time, Robert focused on a law degree. But he did not give up on his dream of being a Marine, going on active duty in 2015.

The pain "felt like daggers"
The heavy packs, long hikes, and extensive running began to take their toll on his previously injured leg, and Robert broke his ankle. After another surgery he suffered severe peripheral nerve damage.

"Immediately after the operation, I had very intense pain,” said Robert. He couldn’t even take a bath because “any contact with the water, regardless of temperature, felt like daggers. I likewise couldn't sleep because my leg felt like it was being crushed in a vise, and every step I took felt like a hammer hitting my leg.”

As the pain progressed “I wasn't able to function as a Marine, a lawyer, or even a husband and father because I couldn't do things we would normally do as a family. And emotionally, that was incredibly difficult to deal with," said Robert.

"We tried so many different medications, but they were not very effective. They also interfered with my ability to think and articulate clearly, which made it tough to do my job."

Relief with a trial period, then an SCS implantation
"We tried opioids, different physical therapies, some electrostimulation devices, acupuncture and more. But I kept getting worse," Robert explained. He even considered amputation.

Then Robert’s pain doctors suggested Abbott's Proclaim™ XR SCS therapy. Robert underwent a temporary trial implant. He used Abbott’s NeuroSphere™ myPath™ app during the trial period. "It allowed me to record my responses to different stimuli, which was helpful information for my doctor," Robert noted. When he had pain relief during the trial period, he decided to have the device implantation.

And now? "The device has given me enough freedom to where I now go back out and do things. I can take long walks and experience things with my friends. I’m not worried that I'll get lost midway through a sentence because of my meds. It's hugely liberating," said Robert.

He also relies on the NeuroSphere™ Virtual Clinic app, which allows him to connect remotely with his doctor. "One of the great things about the app is that no matter where I am, if there's a usable Wi-Fi‡ signal, I can request remote care where my doctors can tailor the device settings to match what I'm experiencing. I am able do all this without ever having to go to [the doctor’s] office, especially because I love to travel and now I can. I get the relief I need whether I'm home or in a hotel room."

He uses the same app to modify his therapy based on his doctor’s prescribed settings. “It is very easy to use, and I tweak and adjust settings as necessary," said Robert. "It doesn't take more than 30 seconds to adjust my spinal cord stimulator, and it helps my mood that I feel like I can depend on the results.”

Now able to carry his daughter on his shoulders
"The times I couldn't chase her around broke my heart because that's all I wanted to do, to spend time with her," said Robert. "A two-year-old can't understand why you scream when she touches your leg. Now that I'm able to push her on the swings and play games, I realize that I can have those moments I thought I'd lost forever.”

Watch the videos

“Getting back to normal life” - Marah’s story
“An innovative path to chronic pain” - Tony’s story

Read the articles

Ashleigh photo
Ashleigh photo
Ashleigh photo

Ashleigh: Pain took away the joys of life, but the right therapy helped restore them

Not long ago, Ashleigh became disabled after badly twisting her ankle. Her doctor was at first puzzled by the source of the pain. Six months later, "if a breeze hit my foot, I would be in crippling pain, like the feeling of being burned. It became unbearable."

She went from being an active mom to her son “to being on the couch all the time. Because walking was too much to handle."

And husband Chris was doing everything that Ashleigh couldn't. "We went from being a true partnership to him doing it all."

Getting a diagnosis, and a neurostimulation device

In time doctors diagnosed her with complex regional pain syndrome (CRPS). CRPS is a burning, stabbing, stinging, or throbbing pain that makes the affected leg extremely sensitive to touch. Pain medications helped at first but became less effective in time.

Abbott has the only FDA-approved neurostimulation device, Proclaim™ DRG, to treat the dorsal root ganglion. And Ashleigh noted that by the time she had her system implanted, “I was at a breaking point. I felt completely overwhelmed. Because that amount of pain changes your brain in ways I can’t even begin to describe."

Yet as soon as the device was “turned on, everything changed for me," she said. Plus NeuroSphere™ Digital Care allows her to receive remote adjustments from her care team when needed, giving her "peace of mind. I know that if there is a problem, wherever I am, I can meet with Dr. Tubic remotely through the NeuroSphere™ Virtual Clinic if I want to. I don't worry anymore."

Maybe just as important, she has been able to resume her career—“all because I have freedom from pain.”

How her life has changed

"The Proclaim™ device [gave] me back my family, my career, and my life," said Ashleigh. "I appreciate things now more than before I was hurt.” She said she is “more motivated to focus on the things I enjoy and truly value.” She’s even able to get in 15,000 steps a day if she can.

As for Ashleigh and her husband, Chris, "our marriage has never been stronger," she said. But even enormous gratitude has its limits. "I haven't done laundry in years. I am not taking that one back."

kevin photo
kevin photo
kevin photo

Kevin: This therapy kept me out of a wheelchair

Pain has been almost a constant companion to Kevin, dating back to 1979. He was in the Navy when his team lost control of a 2,200-pound piece of equipment that landed on his right foot, crushing all of its bones. Over time, due to other military-related injuries, he had 6 knee and 12 shoulder surgeries. But worse pain was to come.

Because his right foot had never properly healed, a neuroma formed between his toes. A neuroma is a mass growing from a nerve, and usually consisting of nerve fibers. Neuromas can form at the site of traumatic injuries and are often extremely painful.

Amputation in an attempt to stop the pain

A surgeon amputated Kevin’s toes to help the pain, but that wasn’t effective. So his right leg was amputated about 8 inches below the knee. Kevin was given opioids after surgery, and he remembers . . . actually very little.

"From the time I woke up from surgery until the opioids were stopped weeks later, I have no memory. They just messed with my mind, fogging it up completely. I hated the feeling," he noted. Then came the phantom limb pain. This is a pain in the area where the limb has been amputated. For Kevin, it was a "throbbing, burning pain, like a thousand wasps stinging in a concentrated area."

When another neuroma formed, a side effect of the amputation, this pain was worse than anything Kevin felt before. And it occurred 5-20 times per day.

Eventually, he suggested neurostimulation to his neurosurgeon. His doctor agreed that Kevin may be a candidate for Proclaim™ DRG therapy, and Kevin was ready. "I really needed a treatment that would work. I knew this pain was ruining my life and the lives of those around me."

The pain was just gone
"I'm generally a positive person so I was feeling pretty good about getting the [DRG] system placed. But in the recovery room I looked at [my wife] and said, ‘It’s not working, Judie.’ I was disappointed, obviously.” Then he heard a voice say, “ ‘Alright, let’s turn this on.' [And] the pain was gone.”

There were some adjustments to the DRG therapy, and since then “I have not felt that neuroma pain again.” And Kevin’s life has become much more active. "Judie and I hike the mountains, bike the trails, work my woodshop, ski the slopes, and scuba whenever we can. I am also part of the local National Ski Patrol team.”

About all of those years he was in pain, Kevin said, "It is exhausting. It's hard on the people you care about you too. I think the Proclaim system has given me back my life and kept me out of a wheelchair. This technology has changed my life. That's way cool."

Marah photo
Marah photo
Marah photo

Marah: After years of pain, and 55 procedures, she found lasting pain relief

Just before Marah entered sixth grade in 2006, she was in a car accident. Her ankle hurt, and doctors hold her it was just a sprain. “I tried to go back to swim practice”—she had actually made it to the Junior Olympics—“and tried to go back to my daily life. But when I had to run a mile in gym, I thought, ‘Oh, this doesn't feel right.’ ”

Marah said she keeping thinking, “Something's wrong, something's wrong. Please fix it.” But eventually the injury “completely took my mobility,” she explained. “I completely lost my ability to walk, and I had to stop swimming.”

Marah had developed complex regional pain syndrome (CRPS). Over time she endured more than 55 procedures and surgeries. And she spent months, then years, either homebound or in the hospital.

It not only affected her physically, it impacted her socially. “I definitely had a huge pause in social milestones, in middle school especially,” she said. “I was that weird kid on crutches. And then I was that weird kid that needed some help to carry their backpack because I couldn't deal with any extra weight.”

Marah tried one spinal cord stimulator “and it failed,” she noted, with “the pain coming back even worse.”

Excited about the option of DRG therapy

Then a doctor gave her information about Proclaim ™ DRG (dorsal root ganglion) therapy. As someone whose ambition was to become a medical doctor, Marah did some research and realized the potential of DRG therapy. After reading about how the therapy targets DRG-related pain from CRPS, she realized “Oh this is a completely different game. I actually called my dad, crying, and said, ‘This is it, this is going to work.’ ”

And after she had her DRG device implanted, she finally found the relief she was looking for. “Once they turned the therapy on, I could completely go off all pain medications. I am completely living a 100% normal, functional life,” she explained.

As an MD, a chance to specialize in pain management

Marah is now working on her MD degree, having received an undergraduate degree in biochemistry and a master's in biomedical science. “Pain management is obviously what I'm most passionate about,” she noted. “I want to focus on innovative medicine. I want to help create devices like this.”

Wherever her career leads, Marah will embrace it with all of the enthusiasm and determination that she has shown throughout her pathway through pain.

tony photo
tony photo
tony photo

Tony: Trying everything, even amputation, before getting relief with DRG therapy

Tony is no stranger to perseverance. He was diagnosed with rheumatoid arthritis at 19. And while working for years as top chef at restaurants across the country, he was known for his culinary skills—but he also endured severe pain.

“My attitude was always: Keep moving through [the pain],” said Tony. Yet he had numerous surgeries and fusing procedures to try and control his pain. And nothing really worked.

“After I [had fusion surgery on] my ankle in 1991, I was never really that mobile. I dragged my leg around,” Tony explained.

"If you want to be mobile, cut it off"

Tony heard this unwelcome advice from a doctor, so at age 40 he made the difficult decision to have his left leg amputated below the knee in the hopes of increasing his mobility.

For a while the amputation helped alleviate Tony’s pain. And with physical therapy, he learned how to get around on one leg, even mastering skiing. But 5 years later, he developed severe nerve pain, diagnosed as complex regional pain syndrome (CRPS). That's when his pain specialist told him about DRG therapy.

Finding a life-changing therapy

Tony initially did a trial period with DRG therapy to see if it could provide some relief. The first day of his trial period, Tony felt so good that he walked 5 miles around New York City.

"It felt great," he said. "Up to that point, I had not walked that far in about 5 or 6 years.” Tony then had a permanent DRG system implanted. And he said he's never felt better. The majority of his nerve pain is relieved, so he’s able to hike again—and even able to go back to skiing. He's now a ski instructor for disabled people.

"For me, it's been a life-changing device," Tony said of DRG therapy. "And I found it because I don't give up."

Tony hopes his story can help other people also suffering from DRG-related pain. "What people need to know is that if you have nerve pain, [DRG therapy] has a huge potential to change the quality of your life,” he said. “For me, it has completely changed the quality of my life.”

rebecca photo
rebecca photo
rebecca photo

Rebecca: Amazed by how well DRG therapy worked

Rebecca is a homemaker, wife of an active military member, and mother of two. She had been treated for chronic pain in her left knee for 10 years. With her life revolving around chronic pain she missed out on activities such as hiking, exercising, and playing with her kids.

Rebecca also dreamed of pursuing a career in nursing but knew that was impossible with her pain. “[Chronic pain] puts a halt on all of your plans,” she said.

For years, no treatments worked

For years she received various treatments for her complex regional pain syndrome (CRPS) of the lower limbs. Her physical therapy left her feeling sore on top of her existing pain. She tried pain medications but worried about the health risks. She also tried epidurals, nerve blockers, and traditional neurostimulation, but none gave her enough relief. Her family worried, while she wondered if she’d ever be pain free.

Learning about DRG therapy

Then Rebecca heard about DRG therapy, which targets nerve cells specific to the area where the pain occurs. She talked with her doctor about the risks and benefits. DRG therapy requires surgery, which exposes people to certain risks.

Yet one of the benefits of the Proclaim™ DRG System is that you can try it first to make sure DRG therapy works for you. When she received a temporary device, she said her pain was relieved about 80%.

Finally, she has nearly 100% pain relief

She decided to receive a permanent implant. Since then, she has experienced almost 100% relief from her pain.

“It is amazing; it took away more pain than I expected it to,” she said. She also wondered what her life would have been like if she had this device 5 or 10 years ago. Now, Rebecca can go for daily walks, keep up with her kids, and pursue that nursing career. Receiving the Proclaim™ DRG System, she said, “was definitely worth it.”

Melissa: Quickly found relief with Abbott SCS system

How bad was Melissa’s chronic pain?

“My husband was pushing me in a wheelchair. I couldn’t do anything. [The Abbott device brought] instant relief. I haven’t taken any pain meds since the day they put it in. I can't even put into words how great it is, because you don't even know it's there and you just have no pain. It's a miracle. It's just a miracle.”

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Important Safety Information

Dorsal Root Ganglion Therapy (DRG) Therapy

Prescription And Safety Information

Read this section to gather important prescription and safety information. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. 

Intended Use

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system. 

Indications For Use

This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).  

Contraindications

This neurostimulation system is contraindicated for patients who are 

  • Unable to operate the system

  • Poor surgical risks 

Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure.

MRI Safety Information

Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. 

For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals). 

For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html

Warnings

The following warnings apply to this neurostimulation system.

Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.

Pediatric use. The safety and effectiveness of neurostimulation for pediatric use have not been established.

Back pain. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated.

External defibrillators. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. After defibrillation, confirm the neurostimulation system is still working.

Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients.

Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient.

Computed tomography (CT). If the patient requires a CT scan, all stimulation should be turned off before the procedure. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range.

  • For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should:

  • Determine the device type

  • If practical, try to move external devices out of the scan range 

  • Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. 

  • Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds.

Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur.

After CT scanning directly over the implanted or externally worn electronic medical device: 

  • Have the patient turn the device back on if it had been turned off prior to scanning.

  • Have the patient check the device for proper functioning, even if the device was turned off.

  • Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan.

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. 

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.

During implant procedures, if electrosurgery devices must be used, take the following actions: 

  • Use bipolar electrosurgery only.

  • Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.

  • Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.

  • Set the electrosurgery device to the lowest possible energy setting.

  • Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. 

Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: 

  1. Maximize the distance between the implanted systems; 

  2. Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and 

  3. Avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system

Other active implantable devices. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown.

Radiofrequency or microwave ablation. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.

Emergency procedures. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion.

Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Restricted areas. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker.

Component manipulation by patients. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection.

Implantation at vertebral levels above T10. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated.

Number of leads implanted. The safety and efficacy of the implantation of greater than four leads have not been evaluated.

Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Excessive lead migration may require reoperation to replace the leads.

Scuba diving and hyperbaric chambers. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system.

Operation of machines, equipment, and vehicles. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 

However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others.

Explosive and flammable gasses. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of these devices could cause them to ignite, causing severe burns, injury, or death.

Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid damage. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.

Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.

Device modification. The equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (i.e., jailbroken).

Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.

Cremation. The IPG should be explanted before cremation because the IPG could explode. Return the explanted IPG to Abbott Medical.

IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.

Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.

Additional Warnings for Leads

Conscious sedation. The placement of the leads involves some risk, as with any surgical procedure. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Use caution when sedating the patient. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage.

Preventing infection. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Use appropriate sterile technique when implanting leads and the IPG.

Lead damage from tools. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead.

Needle positioning. Always be aware of the needle tip position. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures.

Needle insertion. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak.

Advancing components. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Advance the needle and guidewire slowly. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage.

Removing components. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Removing each item in slow movements while holding the remaining components in place will assist this process.

Sheath insertion warning. Insertion of a sheath without the lead may result in dural puncture. Securing the lead with the lead stabilizer will mitigate this risk.

Sheath retraction. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Failure to do so may result in damage to the sheath. Before reinserting the sheath, verify there is no damage to the sheath.

Sheath rotation. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. The tip of the sheath may whip around and could cause harm to the patient.

Lead insertion through sheath. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Do not use excessive pressure when injecting through the sheath.

Removing a kinked sheath. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Failure to do so can damage or cut the lead or sheath. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath.

Providing strain relief. Failure to provide strain relief may result in lead migration requiring a revision procedure.

Anchoring leads. Do not suture directly onto the lead to avoid damaging the lead. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation.

Remove leads slowly. Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Always perform removal with the patient conscious and able to give feedback.

Precautions

The following precautions apply to this neurostimulation system.

General Precautions
  • Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.

  • Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.

  • Implantation of multiple leads. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.

  • High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately.

  • Postural changes. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. However, some patients may experience a decrease or increase in the perceived level of stimulation. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting.

    Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. If unpleasant sensations occur, the IPG should be turned off immediately.

  • Advise patients about adverse effects. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components.

  • Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.

  • Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

  • Battery precaution. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Do not crush, puncture, or burn these devices because explosion or fire may result. Return them to Abbott Medical for proper disposal.

  • Stimulation effectiveness. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Stimulation effectiveness has been established for one year.

Sterilization and Storage
  • Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.

  • Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind. 

Handling and Implementation
  • Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.

  • Package or component damage. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Return any suspect components to Abbott Medical for evaluation.

  • Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

  • Lead inspection. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target.

  • Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

  • Component handling. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function.

  • Using surgical instruments. Do not use surgical instruments to handle the lead. The force of the instruments may damage the lead or stylet.

  • Using the tunneling tool. Use extreme care to not damage the lead with the sharp point of the tunneling tool.

  • Component manipulation. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space.

  • Stylet handling. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Use care when reinserting a stylet. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Remove the stylet from the lead only when satisfied with lead placement. If the stylet is removed from the lead, it may be difficult to reinsert it.

  • Sheath insertion precaution. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura.

  • Stabilizing the lead during insertion. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Failure to do so may cause harm to the patient such as damage to the dura.

  • Bending the sheath. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead.

  • Lead handling. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Failure to do so may result in difficulty delivering the lead.

  • Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.

  • Inserting the anchor. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location.

  • Securing the anchor. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system.

  • Placing the IPG. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG.

  • Securing the IPG. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged.

  • System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

  • Conscious sedation during removal. Always perform removal of implanted components with the patient conscious and able to give feedback.

  • Surgical advice for removal. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Consider seeking surgical advice if you cannot easily remove a lead.

  • Component disposal. Return all explanted components to Abbott Medical for safe disposal.  

Hospital and Medical Environments
  • High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.

  • Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.

  • Transcutaneous electrical nerve stimulation (TENS). Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician.

Home and Occupational Environments
  • Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: 

    • commercial electrical equipment (such as arc welders and induction furnaces) 

    • communication equipment (such as microwave transmitters and high-power amateur transmitters) 

    • high-voltage power lines 

    • radiofrequency identification (RFID) devices 

    • some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy) 

    • and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes)

  • Interference with wireless equipment. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG.

  • Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

  • Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation.

    Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation.

    Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Patients should cautiously approach such devices and should request help to bypass them. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly.

  • Overcommunicating with the IPG. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life.

  • Mobile phones. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system.

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: 

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately.)

  • Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure or breakage

  • Stimulation in unwanted places (such as stimulation of the chest wall)

  • Lead migration, causing changes in stimulation or reduced pain relief

  • Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage

  • Tissue damage or nerve damage

  • Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant

  • Pain or bleeding where the needle was inserted

  • Persistent pain at the electrode or IPG site

  • Escalating pain

  • Seroma (mass or swelling) at the implant site

  • Headache

  • Allergic or rejection response to device or implant materials

  • Implant migration or skin erosion around the implant

  • Battery failure, leakage, or both

  • Hardware malfunction that requires replacing the neurostimulator

  • Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain

  • Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.)

Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. This may occur once the lead is in place and is connected to the neurostimulator and activated. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Additionally, all patients will be awake and conversant during the procedure to minimize the impact.

71376 MAT-2006974 v2.0 | Item approved for U.S. use only.

 

Spinal Column Stimulation (SCS) Systems

Intended Use

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.

Indications For Use

Abbott Medical spinal cord stimulation (SCS) systems are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, nonsurgical back pain (without prior surgery and not a candidate for back surgery), and diabetic peripheral neuropathy of the lower extremities.

Contraindications

This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.

MRI Safety Information

Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. 

For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals). 

For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html

Warnings

The following warnings apply to this neurostimulation system.

Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients. 

Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. 

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure. 

  • Use bipolar electrosurgery only.

  • Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.

  • Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.

  • Set the electrosurgery device to the lowest possible energy setting.

  • Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.

Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.

Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system.

Interference with other devices. Some of this system’s electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.

Operation of machines, equipment, and vehicles. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment.

Explosive and flammable gasses. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of these devices could cause them to ignite, causing severe burns, injury, or death.

Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid damage. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.

Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.

Use in patients with diabetes. Surgical complications and adverse effects may be more frequent and severe in patients with diabetes. The following additional considerations should be made for patients with diabetes:

  • A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) ≥8% (64 mmol/mol).
  • Monitor the patient’s blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes.
  • Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes.

Stimulation modes. The BurstDR™ stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population.

Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.

Device modification. Equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (that is, jailbroken).

Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.

IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.

Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.

Precautions

The following precautions apply to this neurostimulation system.

General Precautions
  • Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.

  • Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.

  • Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.

  • Implantation of two systems. If two systems are implanted, ensure that at least 20 cm (8 in.) separates the implanted IPGs to minimize unintended interaction with other system components.

  • Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.
  • Implant healing. While charging the generator, patients may perceive an increase in temperature at the generator site. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation.
  • High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately.

  • Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
  • Consumer goods and electronic devices. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any smart device in a pocket near the generator. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support.
  • Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) six to eight weeks after implantation of a neurostimulation system. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation.
  • Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.

  • Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

Sterilization and Storage
  • Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.

  • Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.

Handling and Implementation
  • Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.
  • Recharge-by-date. A recharge‑by date is printed on the packaging. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation.
  • Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

  • Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

  • Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation.

  • Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.

  • System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

Hospitals and Medical Environments
  • High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.

  • Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.

  • External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.

  • Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Home and Occupational Environments
  • Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation.
    Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Patients should cautiously approach such devices and should request help to bypass them. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly.

  • Scuba diving or hyperbaric chambers. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician.

  • Wireless use restrictions. In some environments, the use of wireless functions (for example, Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: 

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately

  • Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure

  • Stimulation in unwanted places (such as radicular stimulation of the chest wall) 

  • Lead migration, causing changes in stimulation or reduced pain relief 

  • Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space 

  • Cerebrospinal fluid (CSF) leakage 

  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant 

  • Persistent pain at the electrode or IPG site 

  • Seroma (mass or swelling) at the IPG site

  • Allergic or rejection response to implant materials 

  • Implant migration or skin erosion around the implant 

  • Battery failure

  • Changes in blood glucose levels in response to any adverse effect 

    NOTE: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate preoperative glycemic control. For adverse effects observed in the use of diabetic peripheral neuropathy, refer to the clinical summaries manual for SCS systems.

Safety And Effectiveness Studies

For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system.  

21 CR 801.109(b)  The label of the device, other than surgical instruments, bears:

(1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician,” “dentist,” “veterinarian,” or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and 

(2) The method of its application or use.

 

23-78280 MAT-2215216 v4.0 | Item approved for U.S. use only.

23-80320 MAT-2213611 v2.0 | Item approved for U.S. use only.