Safety Information; Contraindications - Boston Scientific Vercise Mode D'emploi

Safety Information

Contraindications

The Boston Scientific DBS System, or any of its components, is contraindicated for the following:
Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy should not be used
on patients implanted with the Boston Scientific DBS System, or any of the system components.
The energy generated by diathermy can be transferred to the Boston Scientific DBS System,
causing tissue damage at the contact site resulting in severe injury or death.
Magnetic Resonance Imaging (MRI) (Vercise PC Only): Patients implanted with
the full Vercise PC DBS System (DBS Leads, Lead Extensions, and Stimulator) should not be
subjected to MRI. MRI exposure may result in the following:
• Dislodgement of implanted components.
• Heating of the Contacts or other system components, causing permanent tissue
lesioning.
• Damage to the Stimulator's electronics.
• Current induction through the DBS Leads and Vercise PC DBS System causing
unpredictable levels of stimulation.
• Distortion of the diagnostic image.
• Personal injury or death.
Note: The Vercise DBS Lead‑Only System (before Stimulator is implanted), the Vercise Gevia
System, and the Vercise Genus System are MR Conditional. An MRI examination can be
conducted safely when all the instructions in the supplemental manual ImageReady™
MRI Guidelines for Boston Scientific DBS Systems are followed.
For the latest version of the manual, go to http://www.bostonscientific.com/manuals.
Patient Incapability: Patients who are unable to properly operate the Remote Control
and Charging System (when applicable) should not be implanted with the Boston Scientific
DBS System.
Poor Surgical Candidates: The Boston Scientific DBS System is not recommended for
patients who are poor surgical candidates.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Safety Information
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