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Device Failure. Implants can fail at any time due to random component failure, loss of
battery functionality, or DBS Lead breakage. Suddenly stopping brain stimulation can
cause serious reactions to develop. If the Stimulator stops working even after complete
charging (up to four hours when properly aligned), patients should be instructed to turn
off the Stimulator and contact their physician immediately so that the system can be
evaluated and appropriate medical care given to manage the return of symptoms.
Environmental Precautions. Patients should avoid activities that could potentially
involve large amounts of electromagnetic interference. Devices that contain permanent
magnets, such as speakers, should not be placed near the Stimulator because they may
cause the system to turn on or off.
Excess DBS Extension. Coil excess DBS Extension around or below the Stimulator.
Excess wire on top of the Stimulator may increase the potential for tissue erosion or
damage during Stimulator replacement surgery and may interfere with charging.
Massage Therapy. Patients should avoid receiving massage therapy near the implanted
system components. If a patient does receive massage therapy, the patient should inform
the masseuse that they have an implanted device and show him/her where the Stimulator,
DBS Extension, and DBS Leads are located. The patient should have the masseuse avoid
these areas and proceed with caution.
Medical Devices/Therapies. The following medical therapies or procedures may turn
stimulation off, cause permanent damage to the Stimulator, or may cause injury to the
patient:
•
Electrocautery – Electrocautery can transfer destructive current into the
DBS Leads and/or Stimulator.
•
External Defibrillation – Safe usage of external defibrillation has not been
established and damage should be ascertained following defibrillation.
•
Lithotripsy – High frequency signals directed near the Stimulator may damage
circuitry.
•
Radiation Therapy – Lead shielding should be used over the Stimulator to prevent
damage from high radiation. Any damage to the device by radiation may not be
immediately detectable.
•
Transcranial Stimulation – Safe use of electromagnetic therapies, such as
transcranial magnetic stimulation, have not been established.
•
MRI – Patients implanted with the full Vercise DBS System (Leads, Extensions,
and Stimulator) should not be subjected to MRI to avoid damage to the device and
patient harm.
Note: Vercise DBS Lead-only system (before Stimulator is implanted) is MR conditional.
An MRI examination can be conducted safely when all instructions in the
supplemental manual MRI Guidelines for Boston Scientific DBS Systems are
followed.
For the latest version of the manual go to www.bostonscientific.com/manuals.
•
Diathermy – The energy generated by diathermy can be transferred to the
Vercise™ DBS System and may result of damage to the device or patient harm.
Safety Information
Vercise™ DBS Physician Manual
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