A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy

Exclusion Criteria

• •1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
• •2. Escalating or changing pain condition within the past month as evidenced by investigator examination
• •3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
• •4. Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months
• •5. Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
• •6. Subject is unable to operate the device
• •7. Subjects currently has an active infection
• •8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
• •9. Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator