Potential Risks Or Side Effects - SALUDA MEDICAL Evoke SCS User Manual

• Only use the power adapter supplied by Saluda Medical to recharge the Charger.
• Do not touch the power adapter socket on the Charger.
• Do not leave the Charger power adapter plugged in after recharging is complete.
The eCLS is powered by a rechargeable lithium ion battery that can be recharged or replaced
only by your clinician or a Saluda Medical representative.
• Do not open the case of your eCLS, remove or tamper with the eCLS battery.
• Please contact your clinic for recharge or replacement of your eCLS battery.
Disposal of your stimulator, EPC and Charger
• Your eCLS, EPC and Charger should be returned to your physician if you are no longer
using them.
• Your eCLS, EPC and Charger contain batteries that could explode if they are thrown into
a fire.

4.3 Potential risks or side effects

All medical procedures involve some risk of injury, including death. In addition, there may be
risks associated with having a SCS system that are presently unknown or unforeseeable. Despite
all reasonable precautions, you might develop medical complications from having a SCS system.
Potential risks of implantation and use of a SCS system
• Undesirable changes in stimulation sensation and/or location.
• Uncomfortable changes in stimulation (over and/or under stimulation).
• Temporary or persistent post-surgical pain at hardware implantation sites.
• CLS migration or sub-optimal placement, which may result in pain or difficulty in
charging.
• Seroma or hematoma at surgery sites.
• Epidural hemorrhage, spinal cord injury, possible paralysis or other neurological
complications.
• Lead migration or sub-optimal placement, which may result in undesirable stimulation
changes.
• Breakage of the lead, or malfunction or failure of other system components, which may
result in undesirable changes or loss of stimulation.
• Allergic response or tissue reaction to the implanted or external materials.
• Infection that may require hospitalization with intravenous antibiotic therapy.
• Infection that may result in epidural abscess that can lead to neurological harm.
• Cerebrospinal fluid (CSF) leakage with possible fistula formation.
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Evoke® SCS System User Manual
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