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Vercise™ DBS Physician Manual
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Automobiles or other motorized vehicles using a LoJack system or other anti-
theft systems that can broadcast a radio frequency (RF) signal. The high energy
fields produced by these systems may interfere with the operation of the Remote
Control and its ability to control stimulation.
•
Other sources of electromagnetic interference, such as RF transmitters at
television or radio broadcast stations, Amateur Radio or Citizens Band radio
transceivers, or Family Radio Service band transceivers.
Note: When in close proximity, equipment that generates strong electromagnetic fields
might cause unintended stimulation or interfere with wireless communication
even if they comply with International Special Committee on Radio Interference
(CISPR) requirements.
Heat Due to Charging. The Charger may become warm while charging the Stimulator.
The Charger should be handled with care. Failure to use either the Charging Collar or
an Adhesive Patch while charging, as directed, may result in a burn. The Patient should
not charge while sleeping. This may result in a burn. If the patient experiences pain or
discomfort, they should cease charging and contact their physician.
Intracranial Hemorrhage. Special precautions should be taken for patients who are
prone to hemorrhage including patients with coagulopathy, with high blood pressure,
or who are using prescribed anticoagulants. Microelectrode penetration and DBS Lead
insertion can put patients who have a likelihood of intracranial hemorrhages at greater
risk.
Magnetic Resonance Imaging. Patients implanted with the full Vercise DBS System
(Leads, Extensions, and Stimulator) should not be subjected to Magnetic Resonance
Imaging (MRI). MRI exposure may result in:
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Dislodgement of implanted components.
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Heating of the contacts, or other system components, causing permanent tissue
lesioning.
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Damage to the Stimulator's electronics.
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Current induction through the DBS Leads and Vercise DBS System components
causing unpredictable levels of stimulation.
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Distortion of the diagnostic image.
•
Personal injury or even death.
Note: Vercise DBS Lead-only system (before Stimulator is implanted) is MR conditional.
An MRI examination can be conducted safely when all instructions in the
supplemental manual MRI Guidelines for Boston Scientific DBS Systems are
followed.
For the latest version of the manual go to www.bostonscientific.com/manuals.
Other Active Implantable Devices. Stimulators, such as the Vercise™ Stimulator,
may interfere with the operation of implanted sensing stimulation devices such as
pacemakers or cardioverter defibrillators. The effects of implanted stimulation devices on
neurostimulators, such as the Vercise DBS System, are unknown.
Vercise™ DBS Physician Manual
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