Product Info

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

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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

conrmed after the procedure. Ultimately, however, the Stimulator may require explantation

because of damage to the device or patient harm.

• Diagnostic ultrasonic scanning is unlikely to damage the Stimulator if stimulation is

turned off. Testing has been completed to applicable standards.

• 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 Debrillation – Safe usage of external debrillation has not been established

in DBS patients. Debrillation of the patient is unlikely to permanently damage the

implanted device if stimulation is turned off and the debrillator electrode does not come

into contact with any component of the implantable device. 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.

• 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 debrillation, radiation

energy, ultrasonic scanning, X‑ray, or CT scan, observe the following:

• Turn off stimulation at least ve 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 elds, including current, radiation, or high‑output

ultrasonic beams, away from the Stimulator.

• Equipment should be set to the lowest energy setting clinically indicated.

• Conrm the system is functioning properly following the procedure. Turn stimulation on

and observe for the return of therapy to conrm functionality.