Product Info

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

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Safety Information

Contraindications

The Boston Scientic 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 Scientic DBS System, or any of the system components.

The energy generated by diathermy can be transferred to the Boston Scientic DBS System,

causing tissue damage at the contact site resulting in severe injury or death.

Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation

(TMS): The safety of these therapies in patients implanted with the Boston Scientic DBS System

has not been established. It is possible that the energy generated by these therapies can be

transferred to the Boston Scientic DBS System, causing tissue damage that may result in severe

patient 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 Scientic DBS Systems are followed.

For the latest version of the manual, go to http://www.bostonscientic.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 Scientic

DBS System.

Poor Surgical Candidates: The Boston Scientic DBS System is not recommended for

patients who are poor surgical candidates.

Unsuccessful Test Stimulation: The Boston Scientic DBS System should not be used in

patients who experience unsuccessful test stimulation.