SALUDA MEDICAL Evoke SCS User Manual page 6

• Having an MRI scans while you have the Evoke SCS System may:
o Cause significant heating resulting in tissue damage and/or severe injury.
o Damage the CLS and you may need surgery to replace it.
o Cause unintended stimulation such as tingling, shocking or jolting.
• If an MRI scan is suggested for you, it is important that you inform the clinician
recommending the MRI scan that you have an implanted SCS system that is considered
MR Unsafe.
• It is also important that you tell your doctor who looks after you in relation to your
stimulator, if an MRI scan is suggested for you.
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.
• You should turn your stimulator off before undergoing a CT scan.
Implanted cardiac pacemakers or defibrillators may be affected by your Evoke System
• You should not use your Evoke System if you have any implanted cardiac devices, due to
interference between them.
• The effect of other implanted stimulators on your Evoke System is unknown. We
recommend that you should consult your doctor before undergoing implantation of
other medical devices.
Strong electromagnetic fields may cause you discomfort
• Avoid strong electromagnetic fields as they may cause your stimulator to switch off,
cause an uncomfortable or jolting sensation, or affect communication with your EPC.
• Your stimulator may be affected by:
o Security screeners such as those used at department stores, public buildings, and
airports.
▪ Present your Patient ID card and request to go around the screener.
▪ Turn stimulation off if you are required to go through the scanner.
o Power cables and generators.
o Electric arc-welding devices and electric steel smelters.
o Audio speakers that contain strong magnets.
o Anti-theft devices used in shops and libraries.
o Radio communication transmitters or antennas, such as CB radio antennas (see
Section 15.3).
CLIN-UMAN-005176
Evoke® SCS System User Manual
Revision: 4.01 Page 6 of 53