Find important updates about your DBS therapy system and get instructions 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.


Below you’ll find answers to many common questions about deep brain stimulation (DBS) therapy for managing Parkinson’s disease and essential tremor.

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

See more about risks for DBS therapy and the important safety information for the St. Jude Medical Infinity™ DBS system.


    DBS therapy with a system like the St. Jude Medical Infinity™ DBS system can be used in combination with medications to achieve the best results for your condition. Sometimes, however, medication use can be decreased, potentially reducing medication side effects.

    For some people, symptoms may improve immediately after surgery. Others may see improvements over several months. Response to therapy (or improvement in symptoms) continues to improve over time with ongoing programming and medication adjustments.

    Current data show the motor benefits of DBS last for up to five years after the initial surgery.1 Additional studies underway review the longer-term benefits. Unfortunately, movement disorders like Parkinson's disease and essential tremor continue to progress even after DBS therapy, so the exact length of benefit will most likely vary on an individual basis.

    DBS therapy is not a cure for movement disorders. In addition, it is unlikely that it will eliminate all of your symptoms or stop them from progressing. The goal of DBS therapy is to help improve your quality of life and provide an extended period during which your symptoms can be controlled. In addition, you may be able to reduce the amount of your medication you take and reduce medication-related side effects.

    If you were working before surgery, more than likely you will be able to return to work after you recover from surgery. It is likely that you will be able to do other activities that you could not do before. For advice about exercise and other activities, it is best to consult with your doctor.

    Use of a mobile phone is not prohibited, but since interactions between mobile phones and the St. Jude Medical Infinity™ DBS system have not been tested, it is advised that you do not place the phone directly over your device.

    Most people do not feel the stimulation once appropriate settings have been determined. Some people may feel mild and painless sensations during a programming session. These sensations are short-lived and disappear once stimulation settings are readjusted.

    The St. Jude Medical Infinity™ DBS system  IPG contains a battery. At each programming session, your doctor can check the status of your battery. There is plenty of warning before the battery is depleted, so your doctor will know when to schedule a replacement. How long a battery lasts depends upon how much therapy is required to manage your symptoms and the device’s settings. When the battery is near depletion, your doctor will replace the IPG in a simplified, short, minimally invasive procedure. With this type of procedure, the leads usually do not need to be removed or replaced, so the recovery time is often much shorter than the initial system implant.

    DBS therapy is not for everyone and every patient experience may be different, so it is important to talk with your doctor 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.


Use this glossary to learn about common medical terms related to deep brain stimulation (DBS) therapy.

Basal Ganglia: An area of the brain that controls movement using chemical and electrical signals.

Deep Brain Stimulation (DBS): A therapeutic treatment that consists of an implanted device which targets focused areas of the brain to help ease the symptoms of some movement disorders.

Essential Tremor: A neurological condition that causes uncontrollable shaking or rhythmic trembling; also known as tremor.

Implantable Pulse Generator (IPG): A small device, implanted in your body, that sends electrical pulses to leads (thin wires) placed in your brain.

Lead: Thin, insulated wire that delivers electrical signals from a neurostimulator to your brain; the lead in a St. Jude Medical Infinity™ DBS system may be a directional lead.

Movement Disorders: Neurological conditions that affect a person's movement; Parkinson’s disease and essential tremor are movement disorders.

Parkinson's Disease: A slow, progressive brain condition that takes away the control a person has over movement.

Interested in learning more? Discover some support groups for Parkinson’s disease and essential tremor.



While MRI scans are generally safe, routine procedures, they can interfere with the therapy and the way neurostimulator devices work, possibly leading to injury. Before you get an MRI scan with any implanted device, you need to make sure that your device is eligible to receive that kind of scan.

Fortunately, with certain Abbott neurostimulators, you can safely have an MRI scan when the conditions for safe scanning are met. The table below can help you identify which kinds of scans are eligible to have with each of our MR-conditional implanted devices.




icon of an MRI machine

Medical imaging techniques such as MRI scans are often used by doctors when checking for certain health conditions. Some neurostimulation systems are “MRI Ready,” meaning they are designed to allow you to safely undergo an MRI scan under certain conditions.

The following Abbott devices are MRI Ready, within approved parameters. Ask your movement disorder physician to see if your device is safe for an MRI.

For more information about whether or not it is safe to receive an MRI with your device, please refer to the product manual.





Infinity™ DBS System





If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps:

1. Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system.

2. Contact your movement disorders specialist to:

  •  See if you can safely undergo the type of MRI scan prescribed.
  •  Ask about any possible effects the scan may have on your device. Your movement disorders specialist may also provide you with a Patient Eligiblity Form.

3. Schedule your MRI appointment. When scheduling:

  •  Provide the model numbers and locations of your implanted neurostimulation system parts and your movement disorder specialist’s contact information. This information is located on your Abbott Patient ID card and on the Patient Eligibility Form for MRI Scans.
  •  Tell the radiologist about implanted medical devices (including abandoned devices).

4. Fully charge your patient controller before your procedure. For charging instructions, refer to your user guide.

Make sure to bring the following items to your MRI appointment:

  • Abbott Patient ID Card
  • Patient Controller
  • Patient Eligibility Form for MRI Scans (recommended, but not required)

Before your MRI scan, you may need to ensure your system is in MRI mode. It’s important that the MRI clinic understands and can meet the MR conditions and settings required for your implanted neurostimulator.

Learn more about the features of our Abbott neurostimulation systems.




icon of a device crossed through

Some other kinds of common devices may also interfere with the function of some neurostimulators. Use particular caution when you get close to anti-theft or security systems, and ask for assistance to bypass the system. These systems include:

• Airport security screening devices

• Theft detectors and anti-theft devices, such as those used at entrances/exits of department stores, libraries, and other public places

If you have to go through one of these devices, proceed with caution. Move through the device quickly. Once you have passed through the detector or device, be sure to check the status of your neurostimulator.




For more information about MRI safety and your Abbott neurostimulator, and instructions on how to put your device in MRI mode:



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 discover product issues that we feel are important to share with patients and their doctors. If you have any questions or concerns, please contact your Abbott representative or Abbott Customer Service at 1-866-240-6741.

St. Jude Medical Infinity™ DBS System

June 2017

Abbott recently provided doctors and patients with information and instructions for updating software for implantable pulse generator devices. If you have an St. Jude Medical Infinity™ DBS System 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 the St. Jude Medical Infinity™ DBS System.

Abbott sent the following letter to patients who have implantable pulse generator 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. 



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


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.



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

Parkinson’s disease and essential tremor 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.


The American Parkinson’s Disease Association (APDA): The APDA is one of the largest grassroots networks dedicated to fighting Parkinson’s disease. They also sponsor a large network of referral, education, and support services for people affected by this condition.

Davis Phinney Foundation for Parkinson’s: The Davis Phinney Foundation for Parkinson’s provides essential information, practical tools, and inspiration to people living with Parkinson's. Check out their Every Victory Counts e-book, an invaluable resource for helping you live well with Parkinson’s disease. 

The Michael J. Fox Foundation: One of the world’s most recognizable organizations dedicated to fighting Parkinson’s disease, the Michael J. Fox Foundation promotes a number of different ways to get involved with Parkinson’s-related activities in your area.

The Parkinson’s Foundation: The Parkinson’s Foundation is dedicated to helping make life better for people with Parkinson’s disease by improving care and advancing research. They also help connect people with community support for Parkinson’s disease.

Partners in Parkinson’s: Partners in Parkinson’s is a health initiative that aims to fill in the knowledge gap and provide new educational tools and resources for the Parkinson’s community. They offer several different kinds of community support for people affected by Parkinson’s.


The HopeNET: The HopeNET is an organization specifically dedicated to helping connect people affected by essential tremor. Get in touch with one of their organizers to find a support group in your area.

The International Essential Tremor Foundation (IETF): The IETF is a global group focused on providing hope to the essential tremor community worldwide through awareness, education, support, and research. They promote a range of volunteer opportunities to get involved in the essential tremor community.

Tremor Action Network: The Tremor Action Network is dedicated to providing boutique services for people affected by essential tremor, including one-on-one support and guidance to patients, family members, and caregivers. Learn more about the support services they provide.


1. Krack, P., Batir, A., Van Blercom, N., Chabardes, S., Fraix, V., Ardouin, C., … Pollak, P. (2003). Five-year follow-up of bilateral stimulation of the subthalamic nucleus in advanced Parkinson’s disease. New England Journal of Medicine, 349, 1925-1934.




Deep Brain Stimulation (DBS) Therapy

Prescription and Safety Information

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


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.


United States:
The neurostimulation system is indicated for the following conditions:

  • Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) 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.


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 For more information about MR Conditional products, visit the Abbott product information page at


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. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Therefore, physicians should consider the following:

  • Preoperatively, assess patients for the risks of depression and suicide. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated.
  • Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control.
  • If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately.
  • Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider.

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.


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.


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.


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.


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.


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.

Activities requiring coordination. Loss of coordination is a potential side effect of DBS therapy. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming).

Bathing. Patients should exercise reasonable caution when bathing.

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.


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
    • Cramp
    • Worsening existing medical conditions

MAT-2006976 v1.0


MAT-2003164 v2.0

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.

The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?



© 2018 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. 




You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.

The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?