Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs

Inclusion criteria

• Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
• Patient diagnosed with radiculopathy
• Patient diagnosed with neuropathic pain
• Patient is considered by the investigator as a candidate for implantation of a SCS system
• Patient is ≥ 18 years of age
• Patient must be willing and able to comply with study requirements
• Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

Exclusion criteria

• Patient is diagnosed with ischemic pain
• Patient is diagnosed with arachnoiditis
• Patient is diagnosed with complex regional pain syndrome (CRPS I and II)
• Patient is diagnosed with peripheral vascular disease (PVD)
• Patient is diagnosed with diabetic neuropathic pain
• Patient is diagnosed with chronic migraine
• Patient is immune-compromised
• Patient has history of cancer requiring active treatment in the last 6 months
• Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
• Patients with a SCS system or implantable infusion pump implanted previously
• Patient has a life expectancy of less than one year
• Patient is pregnant or is planning to become pregnant during the duration of the investigation
• Patient is unable to comply with the follow up schedule
• Patient needing legally authorized representative
• Patient unable to read and write
• Patient is currently participating in another clinical investigation with an active treatment arm.