Vercise™ Deep Brain Stimulation Systems
accordance with hospital, administrative, and/or local government policy. Alternatively, if you would
like to return this device to Boston Scientific Corporation, contact your sales representative for
return instructions.
Components: The use of components other than those approved and/or supplied by
Boston Scientific and intended for use with the Boston Scientific DBS System may damage the
DBS System, diminish the effectiveness of therapy, and/or put the patient at unknown risk.
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
O.R. 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 Connections: Do not connect the Remote Control USB port to any other device
except to the Remote Control charger provided with it. Do not connect the Charger to any other
device except to the Base Station provided with it. Do not connect the Programming Wand USB
port to any other device except to the USB Cable provided with it.
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.
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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.
Information for Prescribers
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