Vercise™ Deep Brain Stimulation Systems
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Every effort should be taken to keep fields, including current, radiation, or high‑output
ultrasonic beams, away from the Stimulator.
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Equipment should be set to the lowest energy setting clinically indicated.
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Confirm the system is functioning properly following the procedure. Turn stimulation on
and observe for the return of therapy to confirm functionality.
Operating Temperature: The operating temperature of the External Trial Stimulator, Remote
Control, and Programming Wand is 5 °C to 40 °C (41 °F to 104 °F). For proper operation, do not
use the Charging System if the ambient temperature is above 35 °C (95 °F).
Other Models of External Devices: Only the Remote Control, Charging System
(as applicable), Programming Wand, External Trial Stimulator, and Clinician Programmer
that were provided with the Boston Scientific DBS System should be used with the Boston
Scientific DBS System. Other models of these devices will not function with the Boston Scientific
DBS System.
Patient Activities Requiring Coordination: Loss of coordination is a potential side
effect of DBS therapy. Patients should exercise reasonable caution when participating in activities
requiring coordination, including those that they were able to perform prior to receiving DBS
therapy (e.g., swimming).
Patient Activity Following Surgery: During the 2 weeks following surgery, it is important
for the patient to exercise extreme care so that appropriate healing will secure the implanted
components. During this period, the patient should not attempt to move heavy objects. Instruct the
patient to restrict head movements, including extension or flexion of the neck and rotation of the
head, until healing is complete.
Pediatric Patients: Caregivers should know how to use the Remote Control to ensure the
system is on and providing stimulation. Caregivers also need to understand the correct method
for recharging the Stimulator (rechargeable Stimulator only). Healthcare providers and caregivers
need to discuss the predicted time of battery replacement and plan ahead for end of battery life
procedures (non‑rechargeable Stimulator only). If symptoms return, the caregiver should contact
the healthcare provider immediately.
Setscrews: Before tightening Setscrews, always test impedance to confirm electrical
connectivity. Tightening a Setscrew onto a Lead Contact may damage the Contact and may result
in the need to replace the DBS Lead or DBS Lead Extension.
Single Use Only, Do Not Resterilize: For single patient use only. Do not reuse, reprocess
or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of
the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or
cause patient infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury, illness or
death of the patient. Products used during surgery and explanted components are biohazards.
After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy.
Information for Prescribers
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