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

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 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


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


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.

Movement Disorders Surgeon icon


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, and 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 17 years.*,3,4 Learn more about DBS therapy for movement disorders like Parkinson’s >

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Movement Disorders Physical and Occupational Therapy icon


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 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


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.

Movement Disorders DBS Therapy icon

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.


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 17 years.*,3,7 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 >

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There is presently no cure for dystonia, but multiple treatment options are available to help manage symptoms of the disorder. The goal of treatment for dystonia is to help improve your quality of life and allow you to function with as few side effects as possible. Here are some common treatments for dystonia you may discuss with your doctor:

Movement Disorders physical and occupational therapy icon

Physical and speech/vocal therapy

Physical therapists can teach you exercises to improve your muscle strength, control, and coordination. Physical therapy is often prescribed as a supplemental option for people to achieve greater control over their body. Speech therapy can also help people who have trouble speaking or swallowing due to dystonia.

Movement Disorder medication pill bottle icon


Many medications have been shown to improve dystonia, but you will need to work with your physician to determine the best ones for you. Use these medications exactly as your doctor prescribes as they can cause unwanted side effects.

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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.3,4,7 DBS is a targeted, personalized, and removable 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.


Since its introduction more than two decades ago, DBS therapy has been performed on over a hundred thousand people.3,4,7,8 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.


Our St. Jude Medical 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.9

The system itself includes three simple compents:

Movement Disorders DBS Therapy Directional Lead icon


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

Movement Disorders DBS Therapy Stimulator Implant icon


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


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.


Movement Disorders DBS Therapy Components Diagram



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

 DBS Therapy Effective Therapy Without Compromise icon


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

 DBS Therapy Discreet and Easy to Manage Therapy icon


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

 DBS Therapy Comfortable and Convenient Therapy icon


Our DBS therapy has a small recharge-free DBS battery and can be upgraded without surgery. As new technologies are approved, your device can be upgraded wirelessly.

If other therapies or medications 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.


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.3,4



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


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.4

 DBS Therapy Better Off Time icon


DBS can help you control your movements during your medication “off-times.”4

DBS Therapy More On Time icon


DBS can add up to 1.77 hours of quality “on time” compared to using only the best medical therapy alone.4

DBS Therapy Improved Early Stage Symptoms icon


DBS improves motor symptoms more than medication alone.4

 DBS Therapy Effective For Ten Years icon


DBS has helped people with Parkinson’s control their symptoms for 10 years.

Learn more about the proven benefits of the St. Jude Medical Infinity™ DBS system >



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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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.7



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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DBS therapy has been clinically proven to improve the overall quality of life for people living with essential tremor. In fact, nearly 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.7 Some of the other benefits DBS therapy can deliver:

DBS Therapy Improved Tremor Control icon


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

DBS Therapy Better Quality of Life icon


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 >



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
  • Medication has helped with your symptoms but hasn’t controlled them enough
  • 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 various movement disorders, 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 >


charlene essential tremor story

Charlene finds the St. Jude Medical Infinity™ DBS system comfortable and easy to adjust. See how DBS therapy is helping her to enjoy life again.

Please note: This information is not intended to be a substitute for professional medical advice from your physician or other healthcare 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.4

Indicates a third party trademark, which is property of its respective owner.


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. Parkinson’s Disease Foundation. (2018). Understanding Parkinson’s: What is Parkinson’s? Retrieved from http://parkinson.org/understanding-parkinsons/what-is-parkinsons

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. Abbott. (2012). Data on file, Parkinson’s Disease Final Report C-04-01. n = 135.

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


7. Abbott. Essential Tremor Final Report C-04-02. 2014. n = 127.

8. 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

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. Stockholm, Sweden.

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

12. Baizabal-Carvallo, J. F., & Kagnoff, M. N. (2013). The safety and efficacy of thalamic deep brain stimulation in essential tremor: 10 years and beyond. Journal of Neurology, Neurosurgery & Psychiatry, 85(5), 567-572. n = 13



St. Jude Medical is now Abbott Medical

Prescription and Safety Information

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

Intended Use

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

Indications for Use

United States:

The neurostimulation system is indicated for the following conditions:

  • Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications.
  • Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.


The neurostimulation system is indicated for the following conditions:

  • Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinson’s disease.
  • Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor.
  • Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old.


United States:

This system is contraindicated for patients who meet the following criteria:

  • Are unable to operate the system
  • Have unsuccessful test stimulation

The following procedures are contraindicated for patients with a deep brain stimulation system. Advise patients to inform their healthcare professional that they cannot undergo the following procedures:

  • Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy)
  • Electroshock therapy and transcranial magnetic stimulation (TMS)


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.

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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems (available online at manuals.sjm.com). For more information about MR Conditional products, visit the Abbott product information page at sjm.com/MRIReady.


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. Patients should not use this neurostimulation system if they are pregnant or nursing.

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.

If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. If a system does not meet the MR Conditional requirements, consider it MR Unsafe.

High stimulation outputs and charge density limits. Avoid excessive stimulation. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. If the programming of stimulation parameters exceeds the charge density limit of 30 μC/cm2, a screen will appear warning you that the charge density is too high. Charge density can be reduced by lowering the stimulation amplitude or pulse width. For more information, see the clinician programmer manual.

Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet.

Risk of depression, suicidal ideations, and suicide. Depression, suicidal ideation, and suicide have been reported in patients receiving deep brain stimulation therapy for movement disorders, although no direct cause and effect relationship has been established. Preoperatively assess patients for suicide risk and carefully balance this risk with the potential clinical benefit. Postoperatively monitor patients for the presence of any of the following symptoms and manage these symptoms appropriately: depression, suicidal thoughts or behaviors, changes in mood, and impulse control. Emphasize the importance of sustained follow-up and support with all patients and their caregivers and family members.

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

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

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

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.

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.

Radiofrequency or microwave ablation. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.

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

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

Case damage. If the case of the implantable pulse generator (IPG) is pierced or ruptured, 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.

Component disposal. Return all explanted components 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.

Coagulopathies. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

Low frequencies. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). For this reason, programming at frequencies less than 30 Hz is not recommended.

IPG placement. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller.

Return of symptoms and rebound effect. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). In rare cases, this can create a medical emergency.


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.

Especially consider the following additional factors when selecting patients:

  • Level of available support from a caregiver.
  • Expected effect from cessation of therapy, should disease symptoms return unexpectedly.
  • Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device.
  • Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance.
  • Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device.
  • Patient's visual ability to read the patient controller 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).

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 should cautiously approach such devices and should request help to bypass them. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off.

Unauthorized changes to stimulation parameters. Caution patients to not make unauthorized changes to physician-established stimulation parameters.

Damage to shallow implants. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions.

Keep programmers and controllers dry. The clinician programmer and patient controller are not waterproof. Keep them dry to avoid damage. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing.

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

Battery care. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire.

Long-term safety and effectiveness. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinson’s disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI.

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. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

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

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

Skin erosion. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface.

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.

Multiple leads. When multiple leads are implanted, route the lead extensions so the area between them is minimized. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI).

Abandoned leads and replacement leads. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown.

Placement of lead connection in neck. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture.

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.

Electrocardiograms. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Inaccurate ECG results may lead to inappropriate treatment of the patient.

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. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves.

Control of the patient controller. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards.

Activities requiring excessive twisting or stretching. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component.

Component manipulation by patient. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation.

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

Skydiving, skiing, or hiking in the mountains. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead.

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, 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. 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.

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


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