Safety Information; Contraindications - Boston Scientific Vercise Manual De Uso

Physician Manual

Safety Information

Contraindications

The Boston Scientific Vercise™ DBS System, or any of its components,
is contraindicated for:
Diathermy. Shortwave, microwave, and/or therapeutic ultrasound diathermy.
The energy generated by diathermy can be transferred to the Vercise DBS System,
causing tissue damage at the contact site resulting in severe patient injury or death.
Magnetic Resonance Imaging (MRI). Patients implanted with the full Vercise
DBS System (leads, extensions and stimulator) should not be subjected to MRI. MRI
exposure may result in:
• 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 DBS System causing
unpredictable levels of stimulation.
• 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.
Patient Incapability. Patients who are unable to properly operate the Remote
Control and Charging System should not be implanted with the Vercise DBS System.
Poor Surgical Risks. The Vercise DBS System is not recommended for patients
who are poor surgical risks.
Physician Manual
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