NEUROMODULATION
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FINDING THE RIGHT TREATMENT

OPTIONS FOR CONTROLLING PARKINSON’S DISEASE AND ESSENTIAL TREMOR

FINDING THE RIGHT APPROACH FOR YOUR CONDITION

Today, people living with movement disorders like Parkinson’s disease and essential tremor have a number of different treatments to consider – including physical therapy, medication, and surgical options like DBS therapy.

While there’s no cure for these conditions, finding the right treatment can still help you get better control of your symptoms, move more freely, and get back to the daily activities you love – and doing them with the people you care about. Here are a few important treatment options you and your doctor may consider.

PARKINSON’S DISEASE TREATMENTS

Parkinson’s develops slowly and affects every person differently. Fortunately, there are a number of different therapies to help people manage their Parkinson’s symptoms, stay active, and enjoy more of their lives. If you have Parkinson’s, or if you’re caring for a loved one with this condition, you may try several of these approaches over time. Here are a few options to discuss with your doctor:

Movement Disorders Diet and Exercise Healthy Food icon

DIET AND EXERCISE

While no diet or exercise regime has been shown to cure or slow the progression of Parkinson’s, a well-balanced, nutritional diet combined with strength-building, aerobic, and stretching exercises can improve your quality of life. Short bursts of high-intensity, vigorous exercise may be particularly helpful for people with Parkinson’s.1

Patients should avoid activities such as excessive twisting or bending that may put undue stress on the implanted components of the neurostimulation system. These types of activities can cause component fracture or dislodgement which may result in complications.

Movement Disorders Medications Pill Bottle icon

MEDICATIONS

There’s a range of medications that people with Parkinson’s can take for different symptoms of their condition. Most medications for Parkinson’s target one of two types of symptoms: symptoms related to movement (“motor symptoms”) and other Parkinson’s symptoms that don’t involve muscles and motion (“non-motor symptoms”).2 Since Parkinson’s affects each person differently, you and your doctor will work closely together to figure out which medications you need.

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SURGERY

If medication or other therapies aren’t doing enough to control your symptoms, your doctor may suggest a surgical therapy like deep brain stimulation (DBS).  DBS therapy is a personalized, adjustable therapy involving an implanted device that blocks electrical signals from targeted areas in the brain that cause your Parkinson’s symptoms.

If you’ve been living with Parkinson’s for some time, and medication isn’t doing enough to relieve your symptoms, DBS therapy may be an important option for you and your doctor to discuss. It’s a safe and clinically proven treatment that’s been used to help people with Parkinson’s over the past 15 years.*,3,4 Learn more about DBS therapy for movement disorders like Parkinson’s >

Movement Disorders Physical and Occupational Therapy icon

ESSENTIAL TREMOR TREATMENTS5,6

While there’s no cure for essential tremor, a number of different treatments can help you manage the symptoms. If your essential tremor is making it hard to work or go about your daily activities, here are some of the approaches you may want to discuss with your doctor:

Movement Disorders Medications Pill Bottle icon

PHYSICAL AND OCCUPATION THERAPY

Physical therapists can teach you exercises to improve your muscle strength, control, and coordination. An occupational therapist can help you adapt your lifestyle, work, or environment to living with essential tremor.

Movement Disorders BOTOX Injections icon

MEDICATIONS

Your doctor may prescribe one of several kinds of medications to help control the symptoms of essential tremor. Use these medications exactly as your doctor prescribes as they can cause unwanted side effects.

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BOTOX® (botulinum toxin injections)

BOTOX injections may help control your involuntary muscle movements. They can be particularly helpful for head and voice tremors. Each injection usually lasts about 3 months but may become less effective as symptoms progress.

DBS THERAPY

If medication or other therapy isn’t doing enough to control your symptoms, your doctor may suggest deep brain stimulation (DBS). DBS therapy is personalized and adjustable. It involves an implanted device that blocks electrical signals from targeted areas in the brain that cause your essential tremor symptoms. DBS therapy is a safe, clinically proven treatment that’s been used over the past 20 years.*,3,4 It can be an important option for people with essential tremor, especially if your medication isn’t doing enough to control your symptoms or causes side effects you can’t tolerate. Learn more about DBS therapy for movement disorders like essential tremor >

DBS THERAPY FOR PARKINSON’S AND ESSENTIAL TREMOR

Sitting calmly, enjoying a walk – movement disorders like Parkinson’s disease and essential tremor make it difficult to take part in even simple daily activities like these. Now imagine being able to take better control of your symptoms and your movements – so you can get back to enjoying life again. That’s the potential of deep brain stimulation (DBS) therapy.

DBS therapy has proven to be an effective treatment option.,1,2 DBS is a targeted, personalized, and reversible therapy that works by stimulating areas of the brain associated with involuntary movements – reducing symptoms of Parkinson’s and essential tremor, giving you better control of your movements, and freeing you to live a fuller life.

HOW DBS THERAPY WORKS

Since its introduction more than two decades ago, DBS therapy has helped over a hundred thousand people.3,4,7 For people with Parkinson’s disease or essential tremor, DBS therapy can be a safe, effective way to take control of their symptoms and get back to the lives and activities they enjoy.

ABBOTT’S ST. JUDE MEDICAL™ INFINITY DBS SYSTEM: OUR STATE-OF-THE-ART THERAPY

Our Infinity DBS System works much like a pacemaker for people with Parkinson’s and essential tremor. But instead of providing mild pulses of electrical current to your heart, it uses an implanted generator and a thin wire called a lead to send mild electrical pulses to areas of the brain that cause involuntary movements. These pulses interrupt the signals that cause your symptoms.8

The system itself includes three simple compents:

Movement Disorders DBS Therapy Directional Lead icon

DIRECTIONAL LEAD:

A thin wire placed in the area of your brain that affects your involuntary movement. The lead connects to the stimulator and delivers electrical pulses to help interrupt the signals in the brain that cause involuntary movements.9

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STIMULATOR:

An implanted device that sends electrical pulses to help restore more normal signaling in the brain. It is similar to a pacemaker battery and is typically placed in your chest below your collarbone.

Movement Disorders DBS Therapy Patient and Clinician Programmer icon

PATIENT CONTROLLER AND CLINICIAN PROGRAMMER:

Wireless devices you and your doctor use to manage your therapy. Your doctor uses the programmer to turn on and fine tune your therapy. You can turn the therapy on and off or adjust programs and intensity to what your doctor recommends. Abbott’s St. Jude Medical Infinity™ DBS system uses familiar Apple† technology for both the controller and programmer. Learn more about how the DBS system is implanted and read more about day-to-day life with DBS therapy

HOW THE COMPONENTS WORK TOGETHER

Movement Disorders DBS Therapy Components Diagram

STIMULATOR:

 

  • The stimulator sends electrical pulses to the directional lead
  • The directional lead delivers this stimulation to a targeted area of your brain
  • The stimulation interupts brain signals that cause involuntary movements, helping to reduce your symptoms

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THE RESULT: TECHNOLOGY DESIGNED FOR LIFE WITHOUT LIMITS

Personalized, adjustable, the St. Jude Medical Infinity™ DBS System provides precise and convenient therapy that puts people back in control of their Parkinson’s and essential tremor symptoms.

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EFFECTIVE THERAPY WITHOUT COMPROMISE

The revolutionary directional lead provides your doctor options to more precisely target your therapy to help maximize tremor control while potentially limiting side effects.10

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DISCREET AND EASY TO MANAGE

With wireless communication through an app on an Apple† mobile digital device, managing your therapy is simple and discreet.

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COMFORTABLE AND CONVENIENT

Our DBS therapy has the smallest recharge-free DBS battery on the market11 and can be updated without surgery. As new technologies are approved, your device can be updated wirelessly. If other therapies or medications for Parkinson’s or essential tremor aren’t giving you the control you need, DBS therapy may be an option for you and you doctor to consider. Keep reading to learn more about what DBS therapy can do for people with some of the world’s most common movement disorders.

DBS THERAPY FOR PARKINSON’S

If you’re like many people living with Parkinson’s, you may have relied on medication to control your symptoms. But you may also find that your medication isn’t as effective as it once was. If your symptoms are continuing to limit your ability to live a full and active life, it may be time to also consider DBS – a safe, clinically proven therapy for Parkinson’s.12

PEOPLE USING DBS THERAPY HAVE SHOWN SUSTAINED IMPROVEMENT IN QUALITY OF LIFE FOR UP TO 10+ YEARS17

WHY NOW?

Many people with Parkinson’s start out with a single medication that helps control their symptoms for a while. If that medication isn’t effective or loses its effect over time, a doctor may prescribe additional medications or a combination. People with Parkinson’s often try several different kinds of treatments looking for an approach that helps them live the life they want with side effects they can tolerate. At a certain point in that process, you or your doctor may decide it’s time to consider DBS therapy. Here are a few signs that this surgical treatment may be right for you now:

  • Your medication has started “wearing off”: Your usual dose doesn’t last as long anymore
  • Your symptoms return unexpectedly: You have “off times” when your medication should be working
  • Your medication doesn’t control your movements: You have uncontrollable movements (or “dyskinesias”) after your medication has kicked in.

Learn more about Parkinson’s symptoms and find out if its time to consider DBS therapy

BENEFITS OF DBS THERAPY

With a modern, state-of-the-art technology like Abbott’s St. Jude Medical Infinity™ DBS system, DBS therapy can help give you better control of your symptoms and more quality “on” time with your medication, all with limited side effects.12-14

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BETTER "OFF-TIME"

DBS can help you control your movements during your medication “off-times.”15

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MORE "ON TIME"

DBS can add up to 2.5 hours of quality “on time” compared to using only the best medical therapy alone.13

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IMPROVED EARLY -STAGE SYMPTOMS

DBS improves motor symptoms more than medication alone at earlier stages of Parkinson’s.16

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EFFECTIVE FOR 10+ YEARS

DBS has helped people with Parkinson’s control their symptoms for 10 years and beyond.16 Learn more about the proven benefits of the St. Jude Medical Infinity™ DBS system

95.5% OF PEOPLE MANAGING PARKINSON’S WITH DBS THERAPY WOULD RECOMMEND IT TO OTHERS.4

IS DBS THERAPY RIGHT FOR YOU?4

To see if DBS is right for you, start by asking your doctor if you’re a candidate for this surgical approach. It may be the right therapy for you if:

  • You’ve had Parkinson’s for at least 5 years
  • Your primary symptoms include tremors and uncontrolled movements (dyskinesia)
  • Medication has helped control your symptoms, but is becoming less effective or you need more of it, potentially causing side effects
  • You may be a good candidate for surgery because you aren’t suffering from other serious medical, cognitive, or psychiatric conditions

Want to learn more about what’s involved in getting DBS therapy for Parkinson’s? Find out how an implantable DBS system works and read more about day-to-day life with DBS therapy

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DBS THERAPY FOR ESSENTIAL TREMOR

With essential tremor, many day-to-day activities can be become nearly impossible. Dressing, doing chores, even eating and drinking; tremors limit your independence and keep you from enjoying the life you want to live. DBS therapy is a chance to take control and be you again. This surgical treatment is clinically proven to reduce tremors when you move (“action tremors”) and improve people’s quality of life.18

WITH DBS THERAPY, MOST ESSENTIAL TREMOR PATIENTS MAINTAIN BETTER CONTROL OF THEIR TREMOR FOR 10 YEARS OR MORE13

WHEN SHOULD YOU CONSIDER DBS THERAPY FOR ESSENTIAL TREMOR?

Consider asking your doctor about it. You may be a good candidate for DBS therapy if:

  • Your symptoms are having an intolerable impact on your quality of life
  • Medication has helped with your symptoms but has not adequately controlled them
  • Other rehabilitation strategies have become less effective for you
  • You can tolerate surgery well because you aren’t suffering from other serious medical, cognitive or psychiatric conditions

Learn more about symptoms of essential tremor that DBS therapy may help you control

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BENEFITS OF DBS THERAPY

DBS therapy has been clinically proven to improve the overall quality of life for people living with essential tremor. In fact, 9 out of 10 of people in one study reported that they were satisfied or very satisfied with the tremor control they’ve achieved with DBS therapy.18 Some of the other benefits DBS therapy can deliver:

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IMPROVED  TREMOR CONTROL17 

DBS helps people with essential tremor get back to daily activities like handwriting, pouring a drink, and working with their hands.

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BETTER QUALITY OF LIFE18

Both patients and caregivers report that DBS therapy helps people with essential tremor improve their physical and social activity, as well as their mental health. Learn more about Abbott’s state-of-the-art St. Jude Medical Infinity™ DBS system

OVER 96% OF PEOPLE MANAGING ESSENTIAL TREMOR WITH DBS THERAPY WOULD RECOMMEND IT TO OTHERS.19

DBS therapy has been clinically proven to improve the overall quality of life for people living with essential tremor. In fact, 9 out of 10 of people in one study reported that they were satisfied or very satisfied with the tremor control they’ve achieved with DBS therapy.18 Some of the other benefits DBS therapy can deliver:

IS DBS THERAPY RIGHT FOR YOU?

To see if DBS therapy is right for you, start by asking your doctor if you’re a candidate for this surgical procedure. It may be the right for you if:

  • Your tremor symptoms are having an intolerable impact on your quality of life/li>
  • Medication has helped with your symptoms but hasn’t controlled them enough/li>
  • Other rehabilitation strategies have become less effective for you
  • You can tolerate surgery well because you aren’t suffering from other serious medical, cognitive or psychiatric conditions

Want to learn more about what’s involved in getting DBS therapy for essential tremor? Find out how an implantable DBS system works and read more about day-to-day life with DBS therapy

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While DBS therapy is proven to help manage symptoms related to essential tremor, it is important to understand that DBS is not a cure. DBS therapy is not for everyone, so it is important to talk with your physician about the benefits and risks. DBS has risks associated with brain surgery, which may include serious complications such as coma, bleeding inside the brain, paralysis, seizures and infection. Some of these may be fatal. If side effects are intolerable or you are not satisfied with the therapy, the DBS system can be turned off or surgically removed. See more about risks for DBS therapy

FIND A DBS SPECIALIST

Interested in learning more about deep brain stimulation (DBS) therapy for Parkinson’s disease or essential tremor? Search for a DBS specialist in your area.

 

SHARE YOUR STORY

Do you have Parkisnon’s disease or essential tremor and are living a full life with the help of DBS therapy? Share your story with us – and inspire others like you.

Please note: This information is not intended to be a substitute for professional medical advice from your physician or other health care providers. You should always talk with your physician about your treatment and any symptoms you are experiencing.

*Based on market approval date of the first DBS system in the U.S. in 2002.3 Abbott DBS therapy has demonstrated safety and effectiveness out to 5 years.4

Apple is a trademark of Apple, Inc.

References:

1. Michael J. Fox Foundation. Ryerson, N. (2015). Exercising with Parkinson’s disease: Should it be high-intensity? Retrieved from https://www.michaeljfox.org/foundation/news-detail.php?exercising-with-parkinson-disease-should-it-be-high-intensity

2. Michael J Fox Foundation for Parkinson’s Research. (2018). Parkinson’s Disease Medications. Retrieved from https://www.michaeljfox.org/understanding-parkinsons/living-with-pd/topic.php?medication&navid=medication  

3. “Premarket Approval (PMA).” U.S. Food and Drug Administration (FDA) P960009, 31 July 1997,

https://www.accessdata.fda.gov/cdrh_docs/pdf/p960009.pdf

4. Okun, M., Gallo, B. V., Mandybur, G., Jagid, J., Foote, K. D., Revilla, F. J., ... Tagliati, M. (2012). Subthalamic deep brain stimulation with a constant-current device in Parkinson’s disease: An open label randomized controlled trial. The Lancet Neurology, 11(2), 140-149.http://dx.doi.org/10.1016/ S1474-4422(11)70308-8.

5. National Institute of Neurological Disorders and Stroke. Tremor Fact Sheet. (2018). Retrieved from https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tremor-Fact-Sheet

6. Mayo Clinic. Essential Tremor. (2018). Retrieved from https://www.mayoclinic.org/diseases-conditions/essential-tremor/symptoms-causes/syc-20350534

7. Fukaya, C., & Yamamoto, T. (2015). Deep brain stimulation for Parkinson’s disease: Recent trends and future direction. Neurologia Medico-Chirurgica (Tokyo), 55(5), 422-431. http://dx.doi.org/10.2176/nmc.ra.2014-0446

8. Yu, H., & Neimat, J. (2008). The treatment of movement disorders by deep brain stimulation. Neurotherapeutics, 5, 26-36. http://dx.doi.org/10.1016/j.nurt.2007.10.072

9. Marks, W. J. (2011). Deep Brain Stimulation Management. New York, NY: Cambridge University Press.

10. Butson C.R., Venkatesan L. (2014). Comparison of neural activation between standard cylindrical and novel segmented electrode designs, MDS 2014 poster

11. St. Jude Medical. St. Jude Medical Infinity™ DBS System Size Related Claims Memo, Zinc # SJM-INF-0815-0007.

12. Butson C.R., Venkatesan L. (2014). Comparison of neural activation between standard cylindrical and novel segmented electrode designs, MDS 2014 poster.

13. Weaver, F. M. (2009). Bilateral Deep Brain Stimulation vs Best Medical Therapy for Patients With Advanced Parkinson Disease A Randomized Controlled Trial. Journal of the American Medical Association, 301(1), 63. doi:10.1001/jama.2008.929

14. Schuepbach, W.M.M., Rau, J., Knudsen, K., Volkmann, J., Krack, P., Timmermann, L., Deuschl, G. (2013). Neurostimulation for Parkinson’s disease with early motor complications. New England Journal of Medicine 368, 610-622.

15. Obeso, J.A., Guridi, J., Rodriguez-Oroz, M.C., Agid,Y., Bejjani, P., Bonnet, A.M., Wilkinson, S. (2001). Deep-Brain stimulation of the Subthalamic Nucleus or the Pars Interna of the Globus Pallidus in Parkinson’s disease. New England Journal of Medicine 345, 956-963.

16. Schuepbach, W.M.M., Rau, J., Knudsen, K., Volkmann, J., Krack, P., Timmermann, L., Deuschl, G. (2013). Neurostimulation for Parkinson’s disease with early motor complications. New England Journal of Medicine 368, 610-622.

17. Deuschl, G., Paschen, S., Witt, K. (2013). Clinical outcome of deep brain stimulation for Parkinson’s disease. Handbook of Clinical Neurology, 116, 107-128.

18. St. Jude Medical. Essential Tremor Final Report C-04-02. 2014. n = 127.

19. Wharen RE Jr., Okun MS, Guthrie BL, et. al. Thalamic DBS with a constantcurrent device in essential tremor: A controlled clinical trial. Parkinsonism Relat Disord. 2017 Jul: 40:18-26. doi: 10.1016/j.parkreldis.2017.03.017. Epub 2017 Mar 30.

IMPORTANT SAFETY INFORMATION

Deep Brain 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 for unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinson’s disease.

 

Contraindications

Implantation of this neurostimulation system is contraindicated for the following:

  • Patients for whom test stimulation is unsuccessful.
  • Patients who are unable to properly operate the system.

The following procedures are contraindicated for patients that have been implanted with this device:

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 can cause tissue damage at the location of the implanted electrodes, resulting in a 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 replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment.

Magnetic resonance imaging (MRI). Do not use a full body radiofrequency (RF) coil or other extremity coils on patients implanted with a neurostimulation system. Because energy from MRI can be transferred through the implanted system, the potential for heat generation at the location of the electrodes exists. This isolated temperature rise may cause tissue damage at the location of the implanted electrodes, possibly resulting in severe injury or death. Injury can occur during MRI treatment whether the neurostimulation system is turned on or off. All patients are advised to inform their healthcare professional that they should not be exposed to MRI. 

 

Warnings

The following warnings apply to these components.

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

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.

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.

Motor vehicles, machinery, and equipment. Patients should not operate motor vehicles, potentially dangerous machinery, or power tools or engage in any activity that would be potentially unsafe if their symptoms were to return unexpectedly.

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.

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.

Charge density. A risk of tissue damage exists with stimulation parameter settings of high amplitudes and wide pulse widths. Higher amplitude and pulse width settings required to achieve therapy may indicate a system problem or suboptimal lead placement. Parameter values exceeding the charge density limit of 30 μC/cm2 should only be programmed with due consideration of the warnings concerning charge densities. Charge density can be reduced by lowering the stimulation amplitude or pulse width.

Low frequencies. Stimulation frequencies less than 30 Hz may be programmed; however, these frequencies may cause tremor to be driven (i.e., occur at the same frequency as the programmed frequency). For this reason, programming at lower frequencies is not recommended.

 

Precautions

The following precautions apply to this neurostimulation system.         

 

General Precautions

Surgeon training. Implanting physicians should be experienced in stereotactic and functional neurosurgery.

Clinician training. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used.

Patient selection. Select patients appropriately for deep brain stimulation. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen.  

Infection. Follow proper infection control procedures. Infections may 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).

 

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. Detailed information on storage environment is provided in the appendix of this manual.

 

Handling and Implantation

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

Electrical medical treatment. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment.

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.

Psychotherapeutic procedures. The safety of psychotherapeutic procedures, such as electroshock therapy and transcranial magnetic stimulation, which use equipment that generates electromagnetic interference, has not been established.

Electrocardiograms. Neurostimulation pulses may be detected by electrocardiograms.

 

Home and Occupational Environments

Patient activities and environmental precautions. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly.

Mobile phones. The effect of mobile phones on deep brain stimulation is unknown. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. If interference occurs, try holding the phone to the other ear or turning off the phone.

Household appliances. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off.

Therapeutic magnets. Patients should be advised to not use therapeutic magnets. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off.  

Radiofrequency sources. Devices that contain permanent magnets (e.g., mobile telephones, cordless telephones, standard wired telephones, and AM/FM radios) may unintentionally cause the IPG to turn on or off.

 

Adverse Effects

Deep brain stimulation potentially has the following adverse effects:

Possible surgical complications. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); subcutaneous hemorrhage or seroma; hematoma; cerebrospinal fluid leakage or cerebrospinal fluid abnormality; brain contusion; infection or inflammation; antibiotic anaphylaxis; skin disorder; edema; persistent pain at surgery site or IPG site; erosion; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; neuropathy (nerve degeneration); hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusion—transient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; aphasia; deep vein thrombosis; complications from anesthesia; phlebitis (vein inflammation); pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc.); complications from unusual physiological variations in patients, including foreign body rejection phenomena; pneumonia, seizure or convulsions; paralysis (loss of motor function, inability to move); stroke and death.

Possible deep brain stimulation complications. Deep brain stimulation complications include, but are not limited to, the following:

  • Device-related complications

- Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture

- Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture

- Initial jolt or tingling during stimulation; jolting or shocking sensations

- Infection

- Paresthesia

- Lead fracture, migration, or dislodgement

- Misplaced lead

- Extension malfunction, fracture, or disconnect

- Deep brain stimulation system failure or battery failure within the device

- Deep brain stimulation system malfunction or dislodgement

- Spontaneous turning on or off of the IPG

- Allergic or rejection response to implanted materials

- Persistent pain, tightness, or redness at the incision sites or general pain

- General erosion or local skin erosion over the IPG

- Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck)  

- Impaired wound healing (e.g., incision site drainage) or abscess formation

- Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component

  • Stimulation-related complications or other complications

- Worsening of motor impairment and Parkinson’s disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia

- Paresis, asthenia, hemiplegia, or hemiparesis

- Dystonia

- Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance

- Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia

- Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium

- Restless leg syndrome

- Supranuclear gaze palsy

- Hypersexuality or increased libido

- Decreased therapeutic response

- Urinary incontinence or retention

- Diarrhea or constipation

- Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope)

- Difficulty breathing

- Increased salivation

- Weight gain or loss

- Eye disorder including eye apraxia or blepharospasm

- Nausea or vomiting

- Sweating

- Fever

- Hiccups

- Cough

- Cramps

- Worsening existing medical conditions  

- Hypersexuality or increased libido

- Decreased therapeutic response

- Urinary incontinence or retention

- Diarrhea or constipation

- Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope)

- Difficulty breathing

- Increased salivation

- Weight gain or loss  

- Eye disorder including eye apraxia or blepharospasm

- Nausea or vomiting

- Sweating

- Fever

- Hiccups

- Cough

- Cramps

- Worsening existing medical conditions

SJM-NWEB-0718-0050

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