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Deep Brain Stimulation (DBS) device support

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Understanding electromagnetic safety

All items that use electricity or transmit wireless signals have invisible electromagnetic fields around them that may temporarily interfere with your Deep Brain Stimulation device. This is called electromagnetic interference, or EMI for short.

Boston Scientific DBS systems are designed to work properly around most electrical devices. However, some items may affect how your device works. While these effects are usually temporary, we recommend using the following guidelines for safe interaction.

Older husband and wife in the airport looking at a mobile device

EMI and your device

Strong electromagnetic fields can potentially turn stimulation off, cause temporary unpredictable changes in stimulation, or interfere with the communication of the remote control.

If you experience uncomfortable stimulation, turn off the stimulator. If the stimulator suddenly turns off by itself, move away from the area. Next, check the stimulation status with the remote control by pressing the unlock button and observing the screen. The implant may need to be recharged before stimulation can be restarted. Refer to your charging handbook for further information. The following items have especially strong electromagnetic fields and you should avoid or exercise extra precautions when you are around them.

  • Airport security screening devices and theft detectors, such as those used at entrances/exits of department stores, libraries and other public establishments. We recommend that you request assistance to bypass the device. If you must proceed through the device, turn off the stimulator and move through the center of the screener as quickly as possible
  • Tag deactivators, such as those found in retail stores and libraries
  • Power lines or power generators
  • Electric steel furnaces and arc welders
  • Large, magnetized stereo speakers

DBS and your cell phone

While we don’t anticipate any interference caused by cell phones, the full effects of interaction with cell phones and your DBS device are unknown at this time. If you have a concern or problems, please contact your physician.

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TERMS OF USE: The information provided on the Electromagnetic (EMI) Guide should not be considered the exclusive or only source for this information. The table lists a general category of items only and is not intended to be an exhaustive list. The recommendations and precautions may be based on information provided by the manufacturers of the items in question, and specific items within a category may function differently. It is best practice to consult the original manufacturer of the item with potential EMI to verify any specific guidance concerning operation and compatibility with implantable devices. If at any time there is a question about the function and potential for Electromagnetic Compatibility, contact the manufacturer of the item in question for further information. At all times, it is the responsibility of the licensed healthcare professional to exercise medical clinical judgment in a particular circumstance. 
 
The information provided is not intended to be used for medical diagnosis or treatment or as a substitute for professional medical advice. The recommendations and precautions contained in this document apply to device function of Boston Scientific devices. Specifically device susceptibility to electromagnetic interference. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

MRI conditional symbol.

The Vercise Genus™ DBS System, Vercise Genus Mixed System with M8 Adapter, Vercise Gevia™ DBS System, and Vercise™ DBS Lead-only system (before Stimulator is implanted) provide safe access to full-body MRI scans when used with specific components and the patient is exposed to the MRI environment under specific conditions defined in the supplemental manual ImageReady™ MRI Guidelines for Boston Scientific DBS Systems.

US Indication for Use: The Boston Scientific Vercise™ PC, Vercise Gevia™, Vercise Genus™ Deep Brain Stimulation Systems are indicated for use in:

  • Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
  • Bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
  • Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.

The Boston Scientific Vercise Deep Brain Stimulation System is indicated for use in:

  • Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.

Contraindications: The Boston Scientific Deep Brain Stimulation (DBS) Systems are not recommended for patients who will be exposed to the following procedures: Diathermy as either a treatment for a medical condition or as part of a surgical procedure, Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS).  The safety of these therapies in patients implanted with the Boston Scientific DBS System has not been established.  Patients implanted with Boston Scientific DBS Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Patients implanted with the Vercise Gevia or Vercise Genus or Vercise Genus Mixed System with M8 Adapter or Vercise DBS Lead-Only System (before Stimulator is implanted) with ImageReady MRI Technology are Full Body MR Conditional only when exposed to the MRI environment under the specific conditions defined in ImageReady MRI Guidelines for Boston Scientific DBS Systems.  Boston Scientific DBS Systems are not recommended for patients who are unable to operate the system or are poor surgical candidates or who experience unsuccessful test stimulation. 

Warnings: Unauthorized modification to the medical devices is prohibited.  You should not be exposed to high stimulation levels.  High level of stimulation may damage brain tissue.  Patients implanted with a Boston Scientific DBS System may be at risk for intracranial hemorrhages (bleeding in the brain) during DBS lead placement.   Strong electromagnetic fields, such as power generators, security screeners or theft detection systems, can potentially turn the stimulator off, or cause unpredictable changes in stimulation. The system should not be charged while sleeping.  If you notice new onset or worsening depression, changes in mood or behavior or impulse control, or have thoughts of suicide contact your physician or emergency services immediately.  Chemical burns may result if the Stimulator housing is ruptured or pierced.  The Boston Scientific DBS Systems may interfere with the operation of implanted stimulation devices, such as cardiac pacemakers, implanted cardioverter defibrillators, or medication delivery pumps. Patients should operate motorized vehicles or potentially dangerous machinery with caution.  It is unknown if the device may hurt an unborn baby. Your doctor may be able to provide additional information on the Boston Scientific DBS Systems.  For complete indications for use, contraindications, warnings, precautions, and side effects, see DBSandME.com or call 833-DBS-INFO or 833-327-4636

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.