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

Vercise Gevia™ Information for Prescribers

Safety Information

Contraindications

The Boston Scientific Vercise Gevia 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 Gevia DBS System, causing tissue
damage at the contact site resulting in severe patient injury or death.
Patient Incapability. Patients who are unable to properly operate the Remote Control and
Charging System should not be implanted with the Vercise Gevia DBS System.
Poor Surgical Risks. The Vercise Gevia 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.
Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used
on patients implanted with the Vercise Gevia DBS System, or any of the system components. The
Stimulator, whether it is turned on or off, may be critically damaged by the use of diathermy. The
energy generated by diathermy can be transferred to the Vercise Gevia DBS System, causing
tissue damage at the contact site resulting in severe injury or death.
Magnetic Resonance Imaging (MRI). The Vercise Gevia DBS System is "MR
Conditional." An MRI examination can be conducted safely using a 1.5 Tesla horizontal closed
bore MRI system when all instructions and safety information in the supplemental manual
"ImageReady™ MRI Guidelines for Boston Scientific DBS Systems" are followed.
The ImageReady™ MRI Guidelines for Boston Scientific DBS Systems manual appears on the
Boston Scientific website www.bostonscientific.com/manuals. It is important to read the information
in this supplemental manual in its entirety before conducting or recommending an MRI examination
on a patient with a Vercise Gevia DBS System.
Vercise Gevia™ Information for Prescribers
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