Safety Information; Contraindications; Warnings - Boston Scientific Vercise PC Instrucciones De Uso

Vercise™ PC Information for Prescribers

Safety Information

Contraindications

The Boston Scientific Vercise PC DBS System, or any of its components, is contraindicated for the
following:
Diathermy. Shortwave, microwave, and/or therapeutic ultrasound diathermy. The energy
generated by diathermy can be transferred to the Vercise PC DBS System, causing tissue damage
at the contact site resulting in severe patient injury or death.
Magnetic Resonance Imaging (MRI). Patients implanted with the Vercise PC
DBS System 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 even death
Patient Incapability. Patients who are unable to properly operate the Remote Control should
not be implanted with the Vercise PC DBS System.
Poor Surgical Risks. The Vercise PC DBS System is not recommended for patients who are
poor surgical risks.

Warnings

Unauthorized Modification. Unauthorized modification to the medical devices is prohibited.
System integrity could be compromised and harm or injury to the patient could occur if the medical
devices are subjected to unauthorized modification.
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.
Charge Density. High levels of stimulation may damage brain tissue. To maintain safety
limits, the software will display a message when the stimulation level would exceed the limit, and
programming of these settings will be prevented.
Patients may be granted the ability to change stimulation amplitude with the Remote Control. The
software prevents patient controlled amplitude from violating the limit.
Vercise™ PC Information for Prescribers
92190993-02 2 of 459