TARGET Post-Approval Study

Exclusion Criteria

• •Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
• •Subject is currently involved in medically related litigation, including workers compensation.
• •Subject has a life expectancy of less than one year.
• •Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
• •Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
• •Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted.
• •Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.