StimRouter Registry Clinical Protocol

Exclusion Criteria

• •1. Subject has other concomitant treatment or medical condition that, in the opinion of the Clinician, prevents the subject from study participation.
• •2. Subject who, for implantation in the trunk, has an implanted demand-type cardiac pacemaker or defibrillator.
• •3. Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve field Stimulation System (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
• •4. Subject who has an implanted device in the area for StimRouter implantation without sponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) between the StimRouter system and all other active implanted devices.
• •5. Subject who requires, or is likely to require, diathermy at the implant site.
• •6. Subject who requires, or is likely to require, therapeutic ultrasound at the implant site.
• •7. Subject who has a cancerous lesion present near the target stimulation point.
• •8. Subject with a bleeding disorder, which, in the opinion of the investigator, is a contraindication to device placement.
• •9. Subject who has an active systemic infection.
• •10. Subject who is immunocompromised and/ or determined by the Clinician to be clinically inappropriate for the procedure and implant.
• •11. Subject who has an active or existing skin disorder or irritation, which, at the Clinician's discretion, precludes the use of skin gel electrodes.
• •12. Subject who currently require or is likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone: the entire StimRouter lead must be at least 50 cm from the center of the MRI system's bore (the iso-center) and at least 16 cm outside of the MRI coil measured from the edge of the MRI coil.
• •13. Subject who has a history of adverse reactions to local anesthetic (e.g., lidocaine).
• •14. Subject who is pregnant, plan on becoming pregnant, or is breastfeeding during the study period.
• •15. Subject who is participating in any other study that could affect the outcome of the registry, such as a spinal stimulation study.
• •16. Subject who is in litigation related to their pain, or who has a pending or active worker's compensation claim. (A patient receiving long-term medical care from a settled Worker-s Compensation claim would not be excluded.)
• •17. Subject who declines to provide written consent or follow-up.