NEUROMODULATION
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WITH A NEUROSTIMULATOR, STAYING UP-TO-DATE IS IMPORTANT

Find important updates about your neurostimulator system and get directions on how to keep your records and your ID card up-to-date. Explore our FAQs and glossary or reach out to one of our featured support groups for more information.

FAQ: NEUROSTIMULATION FOR CHRONIC PAIN

Below you’ll find answers to many common questions about neurostimulation therapy for managing chronic pain.

Always be sure to discuss these and any additional questions with your doctor.

 

WILL NEUROSTIMULATION CURE MY CHRONIC PAIN?

Neurostimulation is not a cure for pain. It is a therapy that may help reduce your pain to a manageable level, so you can return to a more normal lifestyle.

 

WHAT IS THE DIFFERENCE BETWEEN DRG STIMULATION AND SCS STIMULATION?

Dorsal root ganglion (DRG) stimulation targets pain concentrated in specific areas such as the foot, knee, hip, or groin, due to complex regional pain syndrome (CRPS) or causalgia. Spinal cord stimulation (SCS), including BurstDR™ stimulation, relieves pain that’s more broadly felt in the trunk and/or limbs.

 

WHAT IS THE DIFFERENCE BETWEEN TRADITIONAL NEUROSTIMULATION AND BURSTDR™ STIMULATION?

With traditional SCS neurostimulation, a small device is used to interrupt pain signals before they reach the brain. The painful feeling is replaced with a different feeling, which some describe as a tingling or massaging sensation.

BurstDR™ stimulation, exclusively from Abbott, works similarly. However, BurstDR™ stimulation was designed to manage pain more naturally. It works by mimicking natural patterns found in the brain—modifying pain signals and changing the way your body perceives pain.1 Most patients do not feel any sensation with BurstDR™ stimulation.2 Abbott offers both therapies—giving you the best chance at success.

 

ARE THERE ANY RISKS WITH NEUROSTIMULATION?

Risks associated with the procedure and use of a neurostimulation system include infection, swelling, bruising, undesirable changes in stimulation, and the loss of strength or use in an affected limb or muscle group (e.g., paralysis). Talk to your doctor about the possible complications associated with neurostimulation.

 

IS NEUROSTIMULATION SIMILAR TO TENS?

TENS stands for transcutaneous electrical nerve stimulation. Although neurostimulation and TENS systems both deliver electrical pulses, they are very different in how they work and what type of pain they are designed to manage. A TENS unit is an external device that delivers pulses through pads that are placed directly on the skin over the painful area. TENS is generally not effective for severe chronic pain.

 

IS THIS THERAPY COVERED BY INSURANCE?

The temporary system and implanted system are typically covered by many major insurance plans, Medicare and workers’ compensation programs. You will need to work with your doctor’s office and insurance company to determine your coverage.

 

WILL NEUROSTIMULATION ALLOW ME TO REDUCE MY PAIN MEDICATIONS?

Every patient responds differently to neurostimulation. Many patients are able to decrease the amount of pain medications they take. Other patients are able to change the type of medication they take.

 

CAN A NEUROSTIMULATION SYSTEM HELP ME WITH PAIN IN MULTIPLE AREAS?

In order to help with pain in more than one area, your doctor would need to place the leads (thin wires that deliver electrical pulses) in the right locations. Afterward, he or she could program your neurostimulation system to cover the different areas. To help you get the best possible results, make sure your doctor knows where your pain areas are located.

 

HOW DOES THE TEMPORARY SYSTEM DIFFER FROM THE IMPLANTED SYSTEM?

The components of a temporary system include an external generator and leads. For the temporary procedure, only the leads are placed inside of the body. The leads are then connected to a small external generator that is worn outside the body, typically on your lower back. For the implant procedure, the generator and leads are placed within the body. Learn more about trying a temporary system.

 

I HAVE HEARD THAT THE EVALUATION PROCEDURE IS SIMILAR TO HAVING AN EPIDURAL. IS THAT TRUE?

Yes. In an epidural procedure, a needle is inserted into an area along the spinal column called the epidural space. The needle delivers medication to the areas that are causing you pain. In a temporary evaluation procedure, a needle is also inserted into the epidural space. However, instead of medication, thin wires called leads are inserted through the needle and positioned to deliver the stimulation sensation to the painful areas.

 

DOES THE TEMPORARY EVALUATION PROCEDURE HURT?

Most patients receive some medication to help with any discomfort and anxiety they may feel as the leads are inserted. As a result, most report very little discomfort, if any, during the procedure. However, many report some soreness at the insertion site after the procedure.

 

IS THE TEMPORARY EVALUATION REVERSIBLE?

Yes. One of the benefits of the temporary evaluation is that it is designed to be reversible. The removal of a temporary system is simple and often takes less than a minute. It is frequently performed in a doctor’s office or day surgery center.

 

WHAT CAN I DO DURING THE TEMPORARY EVALUATION? WILL I BE ABLE TO WORK?

 

The purpose of the evaluation is to determine your response to neurostimulation and to find out if it controls your pain throughout the day. You may be encouraged to try light activities, such as walking, to see if neurostimulation relieves your pain during those activities. Your doctor may advise you to avoid strenuous activities during your evaluation. If your job is strenuous, you may or may not be able to return to work. Your doctor will determine what is best for you.

 

WILL MY INSURANCE COVER THE TEMPORARY EVALUATION AND IMPLANTED SYSTEM?

The evaluation procedure and implanted system are typically covered by most major insurance plans, Medicare and workers’ compensation programs. You will need to work with your doctor’s office and insurance company to determine your coverage.

 

WHY DO I NEED PSYCHOLOGICAL EVALUATION BEFORE SURGERY?

Most insurance carriers require a psychological evaluation to address issues that may affect your pain management options. It is possible that you may need to see a psychologist before you start a temporary evaluation.

 

WILL I HAVE TO STOP TAKING MY MEDICATION DURING THE EVALUATION?

While many doctors allow their patients to take medications during the evaluation, every doctor has a different approach. Ask your doctor about taking medication during your evaluation.

 

HOW DOES THE IMPLANTED SYSTEM DIFFER FROM THE TEMPORARY SYSTEM?

A temporary system includes an external generator, leads and a patient controller. An implanted neurostimulation system includes a generator, leads and a patient controller (and if it is a rechargeable system, it also includes a charger). For the temporary procedure, only the leads are placed within the body. The leads are then connected to a temporary generator, so you can receive stimulation. For the implant procedure, the generator and leads are placed inside the body. Typically, the generator is placed in the upper buttock. After the implant procedure, you will receive a patient controller, so you can adjust your therapy settings.

 

DOES THE STIMULATION FROM THE IMPLANTED SYSTEM FEEL THE SAME AS THE TEMPORARY SYSTEM DID DURING THE TEMPORARY EVALUATION?

Most people report that the stimulation feels about the same. Differences can occur in some situations when the position, number and type of leads are adjusted during the implant procedure for more coverage of the pain areas. Programming can also affect the way stimulation feels.

 

WILL THE IMPLANT BE VISIBLE?

It depends on your body shape and size and where the implant is located. For many patients, it is not visible. Some patients can see the outline of the device and feel it just beneath their skin. Abbott offers one of the smallest implantable pulse generators available.

 

CAN I GET AN MRI SCAN WITH AN IMPLANTED SYSTEM?

Abbott has three neurostimulation devices for chronic pain that are MR Conditional within approved parameters: The Proclaim™ Elite Recharge-Free SCS System, Proclaim™ DRG Neurostimulation System, and Prodigy MRI™ SCS Implantable Pulse Generator. Learn more about getting an MRI scans with a neurostimulation system.

 

WHAT ARE SOME OF THE RESTRICTIONS I MAY HAVE WITH AN IMPLANTED SYSTEM?

Your doctor will give you detailed information about restrictions and activities with your system. As a general rule, however, it is important to restrict the amount of bending, twisting and reaching you do for the first six to eight weeks after surgery. This is the time that the area around the leads is healing. There are also some permanent restrictions associated with receiving a neurostimulation system. For example, neurostimulation recipients cannot have diathermy therapy. Be sure to ask your doctor for a complete list of restrictions.

 

 

GLOSSARY: NEUROSTIMULATION FOR CHRONIC PAIN

Use this glossary to learn about common medical terms related to neurostimulation for chronic pain.

BurstDR™ stimulation

A new form of neurostimulation therapy that works by mimicking natural patterns found in the brain; this therapy is believed to address both your physical pain and the way it affects you emotionally.3

Chronic pain

Pain that lasts three to six months or longer, or extends beyond an expected recovery period; it is often the result of an illness or injury.

Clinician programmer

Portable, hand-held device that allows a physician to program your generator.

Dorsal root ganglion (DRG)

A cluster of nerve cell bodies in the spine located in the posterior (rear) region of the various vertebrae along the spine.

DRG stimulation

A new type of neurostimulation therapy designed to manage chronic pain in specific areas of the lower body, such as the foot, knee, hip, or groin.

External pulse generator (EPG)

A generator (or neurostimulator) that is used to try neurostimulation therapy (before having a system implanted in your body); it is worn outside the body and is connected to the leads that are implanted in the area near your spine.

Generator

A small device that sends pulses to leads (thin wires) placed along your spine; also called a neurostimulator or implantable pulse generator (IPG).

Implantable pulse generator (IPG)

A small device, implanted in your body, that sends pulses to leads (thin wires) placed along your spine; also called a generator or neurostimulator.

Lead

Thin, insulated wire that delivers signals from a neurostimulator to nerves along the spine; often placed in an area along your spine called the epidural space.

MR/MRI Conditional

A device is MR or MRI Conditional when its design allows for a person with the device to go through a magnetic resonance imaging (MRI) scanner under certain conditions.

Nerve block

A procedure that involves applying a local anesthetic or steroids directly to a nerve that is causing pain; nerve blocks may relieve pain temporarily by having a numbing effect or by decreasing the swelling of tissues around the nerve.

Neurolysis

A procedure that uses chemicals or extreme temperatures to stop a nerve from sending pain signals to the brain.

Neuromodulation

A therapy that influences the signals sent to the brain through the use of an implanted device, involving the application of electrical signals or through the direct delivery of medication with the use of a drug administration system; spinal cord stimulation and dorsal root ganglion stimulation are two types of neurostimulation therapies offered by Abbott.

Neuropathic pain

A type of pain caused by a malfunction of the nervous system due to an injury or illness. It can be a very stubborn type of pain because it does not usually respond well to standard pain treatments, such as over-the-counter pain medications (for example, aspirin or ibuprofen) or prescription pain medications. Neuropathic pain may be managed by a neurostimulation therapy called spinal cord stimulation (SCS).

Neurostimulation therapy

Neurostimulation, also known as spinal column stimulation (SCS), is a pain management therapy that helps mask pain by blocking pain signals before they reach the brain. It is often used to manage chronic pain in the back, arms or legs. The therapy is delivered by a small device and thin wires called leads that are implanted in the body. When turned on, the system sends mild electrical pulses to nerves along the spinal cord, reducing the feeling of pain and providing what some describe as a more pleasant massaging sensation or, in some cases, simply the absence of pain.

Neurostimulator

A small device that sends pulses to leads (thin wires) placed along your spine; also called a generator or implantable pulse generator (IPG).

Nociceptive pain

A type of pain caused when special nerve endings—called nociceptors—are irritated. It is the type of pain you feel when you burn yourself, twist your ankle or stub your toe. Nociceptive pain usually responds well to pain medications, anti-inflammatory agents, or other drug therapies.

Opioids

Powerful pain medications often prescribed when chronic pain does not respond to first-tier therapies.

Pain specialist

A medical professional with advanced training in diagnosing, treating and rehabilitating people with chronic pain; they often work as part of a team with nurses, physical therapists and mental health professionals.

Paresthesia

Tingling sensation sometimes felt during therapy delivery, produced by traditional or tonic spinal cord stimulation.

Patient controller

Portable, hand-held device that allows you to adjust your stimulation settings.

Program

Instructions or changes to stimulation settings that are put into the patient controller and transmitted to the generator.

Radiofrequency ablation (RFA)

A minimally invasive surgical procedure that blocks nerve pathways to the brain using heat generated by radiofrequency waves to destroy or modulate nerves and tissue at the source of the pain (Abbott provides specialized equipment to doctors for performing radiofrequency therapy).

Spinal column stimulation (SCS)

See neurostimulation.

Traditional or tonic spinal cord stimulation

A traditional form of spinal column stimulation that delivers pulses at a consistent frequency.

Stimulation

Small electrical pulses that produce a tingling sensation that reduces or replaces pain signals.

Stimulation level

Amount of stimulation; can be increased or decreased within a range set up by your doctor.

Transcutaneous electrical stimulation (TENS)

Electrical pulses that are applied to nerve endings through electrodes placed on the skin over the painful area

Interested in learning more? Discover some support groups for chronic pain  >

 

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Chronic pain can make daily life challenging. Fortunately, there are many organizations that can support you along the way. Here are a few that can provide information, support, and advocacy to help make your everyday life more manageable and fulfilling.

CHRONIC PAIN SUPPORT GROUPS

The American Chronic Pain Association (ACPA)

For almost 40 years the ACPA has offered support and education to people with pain and their family, friends, and healthcare professionals.

Their site offers guidance on how to find and set up local support groups for people affected by chronic pain.

Amputee Coalition

The Amputee Coalition is the nation’s leading organization on limb loss, dedicated to enhancing the quality of life for amputees and their families. You can use their site to find a local support group for fellow amputees.

 

Chronic Pain Anonymous (CPA)

CPA is a group dedicated to helping people share their experience, strength, and hope to help solve common problems and help others recover from the disabling effects of chronic pain and chronic illness. Visit their site to search several different kinds of meetings.

The International Pain Foundation (iPain)

iPain is dedicated to promoting education, awareness, community and access to care for people with pain-related conditions. Check out their calendar of events for opportunities to connect with resources in your area.

Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)

Reflex Sympathetic Dystrophy Syndrome Association (RSDSA) is an organization dedicated to providing support, education, and hope to all affected by the pain and disability of CRPS/RSD. See some of their inspiring stories on their stories of hope page

The U.S. Pain Foundation (USPF)

The USPF is dedicated to empowering, educating, connecting, and advocating for people living with chronic conditions that cause pain. They sponsor several different support programs for people with chronic pain and their caregivers.

 

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UPDATE YOUR DEVICE ID CARD INFORMATION

If you received your device in the United States, Canada, or Australia, you can update your device ID card or request a new device ID card using the form below.

If you received your device in a country other than the United States, Canada, or Australia, please contact the Abbott distributor in your area.

Note: All physician information fields in the form below are optional. However, if you are providing information for a new physician, please provide at least a first name, last name, postal address, and office phone number.

* Indicates a required field

DEVICE RECIPIENT INFORMATION
DEVICE INFORMATION
PHYSICIAN INFORMATION
SUBMIT YOUR UPDATES

By submitting this form, you are giving permission to allow Abbott to contact you about your request. You can opt out of receiving information from Abbott at any time by following the instructions in the correspondence that you receive.

To ensure your privacy, Abbott will not sell or share your personal information with any third parties or outside mailing lists except as required by law or as stated in our Privacy Policy. Also see our Terms & Conditions.

 

 

PRODUCT ADVISORIES

Abbott is committed to presenting information with accuracy and integrity. As part of our effort to provide the most reliable medical products, we will occasionally publish notices here if we have important information to share with patients and doctors. If you have any questions or concerns, please contact your Abbott representative or Abbott Customer Service at 1-866-240-6741


PROCLAIM™ ELITE SCS IMPLANTABLE PULSE GENERATOR (IPG) JUNE 2017

Abbott recently provided doctors and patients with information and instructions for updating software for implantable pulse generator (IPG) devices. If you have a Proclaim™ Elite SCS IPG implanted before June 2, 2017, there is a software update for the new “Surgery Mode” software feature that applies to your device.

 

Learn how to download the software upgrade for Proclaim™ Elite SCS neurostimulation system.

Abbott sent the following letter to patients who have implantable pulse generator (IPG) devices.


Important Medical Device Advisory: Proclaim™ Elite SCS and St. Jude Medical Infinity™ DBS Neurostimulation Systems

 

Surgery Mode Feature Brochure

 

To learn more, read the answers to frequently asked questions about the “Surgery Mode” software feature.


 

EON™ CHARGING SYSTEM EXCHANGE

JULY 2014


Abbott has provided doctors and patients with information and instructions for exchanging older Eon™ charging systems (Models 3701 and 3711) for the new Model 3726. This action is an update to the initial Eon™ and Eon Mini™ charging system announcement and corrective action that began in July 2012. Abbott is sending out the following letter to patients with an Eon™ charging system.

 

Important Medical Device Safety Information Eon™ Charging System July 2014 


EON™ AND EON MINI™ CHARGING SYSTEMS

JULY 2012

 
Abbott has provided doctors and patients with information about their Eon™ and Eon Mini™ Charging Systems (Models 3701, 3711 and 3721).

If you have an Eon™ or Eon Mini™ Charging System and you have any questions or concerns, please contact your Abbott representative or Abbott Neuromodulation Division at 1-866-240-6741. Abbott sent the following letter to patients who have an Eon™ or Eon Mini™ Charging System to inform them about this issue:

 

Important Patient Information Eon™ and Eon Mini™ Charging Systems July 2012

If you require the replacement of external parts of your system, please contact Abbott (formerly St. Jude Medical) Technical Services at 1-800-727-7846 (Option 3) to see if your equipment is covered under warranty. 

If your equipment is not covered by warranty, the Technical Services staff will give you the option of having Continuum Services facilitate your equipment replacement. Non-warranty replacement equipment requires a signed prescription. Continuum Services will work with the patient, the authorized prescriber, and the insurance company to get the prescription and arrange for insurance billing. For more information, visit Continuum online or call 877-217-1485. Email inquiries may also be sent to NMD@abbott.com.

FIND A PAIN SPECIALIST

Interested in learning more about neurostimulation for your chronic pain? Search for a doctor in your area who specializes in pain management.

 
IMPORTANT SAFETY INFORMATION

Spinal Cord Stimulation

Prescription and Safety Information

Read this section to gather important prescription and safety information.

 

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 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 and intractable low back and leg pain.

 

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 manuals.sjm.com). For more information about MR Conditional products, visit the Abbott product information page at neuromodulation.abbott.

 

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.

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.

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.

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.

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.

 

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.

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).

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.

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.)

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.

 

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.

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.

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.

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.

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.

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.

 

Adverse Effects

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

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.)
  • Stimulation in unwanted places (such as radicular stimulation of the chest wall)
  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
  • Persistent pain at the 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

Dorsal Root Ganglion (DRG) Therapy

Prescription and Safety Information

Read this section to gather important prescription and safety information.

 

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 the management of chronic, intractable pain.

 

Contraindications

This system is contraindicated for patients who are

  • Unable to operate the system
  • Poor surgical risks
  • Pregnant
  • Under the age of 18

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 manuals.sjm.com). For more information about MR Conditional products, visit the Abbott product information page at neuromodulation.abbott.

 

Warnings

The following warnings apply to this neurostimulation system.

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.

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.

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

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.

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 gases. 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.

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 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.

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.

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.

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.

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.

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).  

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.

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

  • 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

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

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.

 

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