SCS for the Treatment Of Chronic Pain of the Upper Extremities

Exclusion Criteria

• •1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures.
• •2. Have a current diagnosis of a progressive neurological disease.
• •3. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
• •4. Have mechanical spine instability as determined.
• •5. Have significant stenosis, based on MRI.
• •6. Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
• •7. Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
• •8. Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
• •9. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
• •10. Be involved in an injury claim under current litigation.
• •11. Have a pending or approved worker's compensation claim.
• •12. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist.