OPTIONS Spinal Cord Stimulation Programming Parameters

Prospective, multi-center, open-label study evaluating programming options in spinal cord
stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation
(SCS) device trial that includes an intraoperative programming trial. Subjects experiencing
a positive response to the programming parameters (improvement in average overall pain
relief) during the trial from baseline will move forward with a permanent implant. Those not
reporting a positive response to the programming parameters will be exited from the study.

The subjects will complete a number of assessment worksheets to characterize their Quality
of Life and function and the level of pain they are experiencing from the baseline to 3
months post neurostimulation trial.

Inclusion Criteria:

- Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled
indication(back and leg pain)

- Willing and able to provide a signed and dated informed consent

- At least 18 years old at the time of informed consent

- Willing and able to attend visits and comply with the study protocol

- Capable of using the patient programmer and recharging the neurostimulator

- Willing to not increase pain medications from baseline through the 3-Month Visit

Exclusion Criteria:

- Currently enrolled in or plans to enroll in any concurrent drug and/or device study
that may confound study results.

- Psychological or other health conditions that would interfere with the subject's
ability to fulfill the requirements of the protocol.

- Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation
or an implantable intrathecal drug delivery system

- Implanted with a cardiac device (e.g., pacemaker, defibrillator)