A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)
A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)
18-SMI-2013 is a post market, observational, questionnaire based study to assess the
 effectiveness of the commercially available Axium neurostimulator in the management of
 chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)
Inclusion Criteria:

 1. Subject is at least 18 years old

 2. Subject is able and willing to comply with the follow-up schedule and protocol

 3. Chronic pain following surgical lumbar discectomy for at least 6 months

 4. Failed conservative treatments for chronic pain including but not limited to
 pharmacological therapy, physical therapy and interventional pain procedures for
 chronic pain

 5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the subjects
 primary area of pain

 6. Subject is able to provide written informed consent

 Exclusion Criteria:

 1. Female subject of childbearing potential is pregnant/nursing or plans to become
 pregnant during the course of the study

 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 implantable cardioverter
 defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump

 6. Subject is unable to operate the device

 7. Subjects with indwelling devices that may pose an increased risk of infection

 8. Subjects currently has an active infection

 9. Subject has participated in another clinical investigation within 30 days

 10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the
 investigator, precludes participation

 11. Subject has been diagnosed with cancer in the past 2 years.

 12. Subject has an anatomical spinal abnormality which is anticipated to require further
 surgery