Boston Scientific Vercise Mode D'emploi page 12

Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Connections: Before inserting any DBS Lead or DBS Lead Extension into any Connector
or Header ports, including the Stimulator Header, DBS Lead Extension Connectors, and
OR Cable Assembly, always wipe the DBS Lead with a sterile, dry cotton sponge. Contamination
inside the Connector or Header ports may be difficult to remove and can cause high impedances,
preventing electrical connectivity which may compromise the integrity of the stimulation circuit.
Delayed Effectiveness: Patients may experience a delayed effect in symptom control from
DBS therapy. Patients and caregivers should be made aware that optimal symptom control may
require frequent programming adjustments over a period of several weeks to months.
Device Failure: Implants can fail at any time due to random component failure, loss of battery
functionality, or DBS Lead breakage. Stopping brain stimulation suddenly can cause serious
reactions to develop. If the Stimulator stops working, patients should be instructed to turn off the
Stimulator and contact their healthcare provider immediately so that the system can be evaluated
and appropriate medical care can be 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 DBS System to
turn on or off.
Excess DBS Extension: Coil excess DBS Lead Extension around or below the Stimulator.
Excess wire on top of the Stimulator may increase the potential for communication interference,
tissue erosion, or damage during Stimulator replacement surgery.
Inspect Packaging Before Use: Check the expiration date on the package before opening
the sterile package and using the contents. Do not use the contents if the current date is past the
expiration date, if the package is opened or damaged, or if contamination is suspected because of
a defective sterile package seal.
• Inspect the seal integrity of the outer tray before use.
• Open the inner tray in the sterile field.
• If the Stimulator was dropped, do not implant it in a patient. The dropped Stimulator
may have lost sterility, experienced a loss of hermeticity, or been otherwise damaged.
Replace the dropped Stimulator with a new, sterile Stimulator prior to implantation.
Return the damaged Stimulator to Boston Scientific.
• Do not use any component that shows signs of damage.
• Do not use if "Use By" date has expired.
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 Lead Extensions, and DBS Leads are located. The patient should advise the masseuse to
avoid these areas and proceed with caution.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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