Algovita Spinal Cord Stimulation System Hi-Fi Study

Inclusion Criteria:

• Patients with FBSS defined as persistent or recurrent back and/or leg pain despite oneor more anatomically successful back surgeries for the same original pain.
• Age 18-75 years old at consent.
• Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
• ODI score of 41-80 out of 100 at the Baseline visit.
• Appropriate candidate for the surgical procedure and Algovita SCS therapy based on theclinical judgment of the investigator and the Algovita Instructions for Provider (IFP)in the Nuvectra product manuals.
• On stable pain medications for at least 28 days prior to consent. Stable is defined asno new or discontinued pain medications and no changes to total daily dose of any painmedications.
• Willing and capable of providing informed consent.
• Willing and able of complying with the study-related requirements, procedures, andvisits.
• Speaks English as a primary language (as the Algovita patient manuals are onlycurrently available in English).
• Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), asdetermined by the investigator.

Exclusion Criteria:

• Has a medical/psychological/psychiatric condition/disorder that could interfere withstudy procedures as determined by the investigator.
• Has a coexisting pain condition that might confound pain ratings, as determined by theinvestigator.
• Has a condition currently requiring or likely to require the use of MRI or diathermy.
• Has an existing drug pump, SCS System, or other active implantable device.
• Has any prior SCS experience.
• Pregnant or planning to become (if female and sexually active, subject must be using areliable form of birth control, be surgically sterile, or be at least 2 yearspostmenopausal).
• For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or withinthe 3 months prior to the Baseline visit).
• Participating in another clinical trial that could affect the outcomes or requirementsof this study as determined by the investigator.
• Involved in an injury claim under current litigation or have a pending or approvedworkers compensation claim.