Document Reference: ENG-UMAN-000730
Revision: 6.00
Page 6 of 40
4
Safety Information
Patients must be advised of the following warnings and precautions (sections 4.1 and 4.2):
Warnings
Diathermy
•
Patients implanted with the Evoke™ System should not be subjected to shortwave,
microwave and/or therapeutic ultrasound diathermy.
•
Diathermy generates energy that may cause heating at the lead site resulting in
damage to the CLS, tissue damage, severe injury or death.
Magnetic Resonance Imaging (MRI)
•
As the Evoke™ System has not been tested for MRI compatibility, it is considered
MRI unsafe. Patients implanted with the Evoke™ System should not be subjected to
MRI as it may result in significant heating and/or tissue damage.
•
MRI exposure can damage the CLS, potentially requiring device explantation and
replacement.
•
MRI exposure may also induce currents through the leads and stimulator leading to
unintended stimulation, such as tingling, shocking, or jolting.
CT Scans
•
Patients implanted with the Evoke™ System may experience a momentary increase
in stimulation when receiving a CT scan. Some patients have described this as
uncomfortable stimulation, jolting or a shocking sensation.
•
Prior to a patient undergoing a CT scan, turn the neurostimulator off.
Electrosurgery
•
Patients implanted with the Evoke™ System should not be subjected to
electrosurgical techniques, such as electrocautery, in close proximity to the Evoke™
System components.
o
Electrosurgical devices generate energy that may cause tissue damage at the
lead site and result in severe injury.
o
Damage may also occur to the CLS
Interference with implanted cardiac devices
•
The Evoke™ System may interfere with other implanted stimulators with sensing
capabilities such as demand type pacemakers or cardioverter defibrillators.
•
The effects of implanted stimulation devices on the Evoke™ System is unknown.
Stimulator damage
•
If the CLS case is ruptured or pierced, then patient tissue may be exposed to battery
chemicals, which could lead to burns or tissue damage.
o
Do not implant the CLS if the case is damaged.
