Boston Scientific Vercise Mode D'emploi page 13

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.
If any of the procedures below is required by medical necessity, the procedure(s) should be
performed as far from the implanted components as possible. Stimulator function should be
confirmed after the procedure. Ultimately, however, the Stimulator may require explantation
because of damage to the device or patient harm.
• Electrocautery – Electrocautery can transfer destructive current into the DBS Leads
and/or Stimulator. See additional instructions below. Bipolar or monopolar electrocautery
may be used. Electrocautery probes must be kept a minimum of 1 inch away from the
implanted device.
• External Defibrillation – Safe usage of external defibrillation has not been established
in DBS patients. Defibrillation of the patient is unlikely to permanently damage the
implanted device if stimulation is turned off and the defibrillator electrode does not come
into contact with any component of the implantable device. Testing has been completed
to applicable standards.
• Diagnostic ultrasonic scanning is unlikely to damage the Stimulator if stimulation is
turned off. Testing has been completed to applicable standards.
• Lithotripsy – High frequency signals directed near the Stimulator may damage circuitry.
See additional instructions below.
• 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.
• X-ray and CT scans may damage the Stimulator if stimulation is on. X-ray and CT scans
are unlikely to damage the Stimulator if stimulation is turned off.
If the patient is required to undergo lithotripsy, electrocautery, external defibrillation, radiation
energy, ultrasonic scanning, X‑ray, or CT scan, observe the following:
• Turn off stimulation at least five minutes before the procedure application.
• All equipment, including probes, ground plates and paddles, must be used as far away
from the Stimulator as possible and oriented such that energy is not directed through or
across the Stimulator, Leads, or Lead Extensions.
• Every effort should be taken to keep fields, including current, radiation, or high‑output
ultrasonic beams, away from the Stimulator.
• Equipment should be set to the lowest energy setting clinically indicated.
• Confirm the system is functioning properly following the procedure. Turn stimulation on
and observe for the return of therapy to confirm functionality.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Safety Information
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