Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator

To evaluate sustainable pain control utilizing the Prodigy or Proclaim Elite family of
neurostimulators using a tonic or BurstDR waveform. Subjects will be enrolled prior to their
device trial evaluation period. Once the subject has their permanent system implant, they
will return to the clinic for follow up visits at 3, 6, 12, 18 and 24 months post permanent
implant.

Inclusion Criteria:

1. Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral
or bilateral pain associated with the following: failed back surgery syndrome and
intractable low back and leg pain.

2. Subject has a score of 6 or higher on the NRS for average pain specific to the area(s)
of chronic pain being treated over the past 24 hours at the baseline visit.

3. Subject is considered by the Investigator as a candidate for implantation of a spinal
cord stimulator system according to the system Instructions For Use.

4. Subject is 18 years of age or older at the time of enrollment.

5. Subject is willing to cooperate with the study requirements including compliance with
the regimen and completion of all study visits.

6. Subject has signed and received a copy of the Ethics Committee/Institutional Review
Board (EC/IRB) approved informed consent.

Exclusion Criteria:

1. Subject currently has a spinal cord stimulation system implanted.

2. Subject has previously failed SCS therapy (either trial system evaluation or permanent
implant).

3. Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris,
or Chronic Migraine.

4. Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral
Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or
implantable infusion pump.

5. Subject is currently participating in another clinical investigation with an active
treatment arm.

6. Subject unable to read and/or write.