Important Safety Information
Patients should consult a physician to understand the potential benefits and risks of treatment associated with Spinal Cord Stimulation (SCS). All patients do not respond the same way to SCS and experiences may vary.
Indications for Use:
The Saluda Medical Evoke SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
Contraindications:
The Evoke System must not be used in patients who:
- Are unable to operate the Evoke System.
- Are unsuitable surgical candidates.
- Are unsuitable candidates for SCS.
Safety Information
Please see Evoke System manuals for detailed safety information regarding the Evoke System, including the following Warnings / Precautions and Adverse Effects:
Warnings / Precautions:
Diathermy, magnetic resonance imaging (MRI) scans, CT scans, implanted cardiac pacemakers or defibrillators, electromagnetic fields, charging the stimulator, other medical procedures, allergies to system components, cables and small parts, pregnancy, paediatric use, operation of equipment, care after surgery, scuba diving, extreme temperatures, and device damage.
Adverse Effects:
May include: undesirable changes in stimulation sensation and/or location; uncomfortable changes in stimulation (over and/or under stimulation); persistent post-surgical pain at hardware implantation sites; CLS migration, which may result in pain or difficulty in charging; seroma or hematoma at surgery sites; epidural haemorrhage; spinal cord injury and possible paralysis; lead migration resulting in stimulation changes; breakage of the lead or failure of other system components, which may result in loss of stimulation; rejection of or allergic reaction to the implanted components; infection; cerebrospinal fluid (CSF) leakage; inadequate pain relief; erosion of the lead or CLS through the skin; weakness or numbness.
Additional information about the Evoke System, including system manuals, may be found on our website, www.saludamedical.com. If you have any further questions, please contact your pain management team. Alternatively, you can contact Saluda Medical via the details above or email us at info@www.saludamedical.com.
CLIN-MKT-007678-EN Rev 2.00