Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy

Post Market Evaluation of Real World Outcomes and Durability to Support Implantable SCS Therapy (PERSIST) Addendum - Inceptiv™ Spinal Cord Stimulation (SCS) Therapy

The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR). The purpose of PERSIST is to generate long-term evidence for the Inceptiv™ Spinal Cord Stimulation therapy.

Inclusion Criteria:

1. 18 years of age or older

2. Patient must be SCS therapy naïve

3. A clinical decision was made for the patient to receive an Inceptiv™ SCS system (pending satisfactory results from a Medtronic SCS trial) limited to on-label leads based on the specific geography for an on-label indication prior to enrollment in the study.

4. Patient is on stable opioid dosage for 3 months prior to enrollment, if applicable

5. Pain intensity of ≥ 6 as measured using the NPRS (0-10) in the predominant area(s) of pain that SCS is intended to treat

6. Patient must have an on-label indication specific to geography.

   • NOTE: Patients may be enrolled if they have upper limb radicular limb pain, related or unrelated to spine surgery
   • NOTE: In the US, patients experiencing chronic back pain without a history of spine surgery and not eligible for spine surgery are on-label candidates for SCS if the pain is associated with degenerative disc disease, herniated disc, or radicular pain syndrome. Radicular pain syndrome (with or without prior spine surgery) is an approved indication for SCS implant.

7. Diagnosis of chronic back and/or limb pain for an on-label indication lasting at least six months.

Exclusion Criteria:

1. Has any existing or is planning to have a new active implantable neuromodulation device or system during the 5 year follow up period (e.g., peripheral nerve stimulation, sacral neuromodulation, intrathecal drug delivery system, a second SCS system)

2. Has a complex pain pattern that involves both upper and lower limbs or back and upper limb

3. Has a planned major medical procedure within 6 months before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator

4. Has a planned interventional procedure within 6 weeks (+/- 2 weeks) before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator

5. Major untreated or unstable psychiatric comorbidity, such as suicidal ideations, personality disorders, schizophrenia etc., that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study, as determined by the Investigator

6. Subjects with PCS total score >30 are not eligible unless ALL of the following are met:

   1. Absence of uncontrolled major psychiatric disorder or active suicidality based on clinical evaluation.
   2. Investigator documentation of adequate understanding of therapy, realistic expectations, and anticipated compliance with protocol follow-up

7. Major non-indicated, untreated or refractory progressive disease (e.g., neurodegenerative disease {not including Diabetic Peripheral Neuropathy}, heart failure, cancer, osteoarthritis, fibromyalgia, chronic fatigue syndrome), or injury (e.g., fall resulting in hip fracture) that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study as determined by the Investigator

8. Has inpatient or outpatient admissions for drug or alcohol dependency within past 12 months or current/ongoing substance abuse

9. Has a current prescription of ≥90 morphine milligram equivalents (MME) per day

10. Has predominant mechanical back pain arising from facet or sacroiliac joint pain as the main cause of chronic low-back pain if low-back pain is the predominant pain condition, as determined by the Investigator

11. Has mechanical spine instability (eg. Spondylolisthesis grade 2) as determined by the Investigator

12. Has an active systemic or local infection that would delay trial or implant

13. Is pregnant or planning on becoming pregnant

14. Has a life expectancy of less than 1 year

15. Involved in an injury claim, under current litigation, beneficiary of an injury claim, receiving worker's compensation, or planning any future litigation

16. Has a condition that the Investigator determines would significantly increase perioperative risk (e.g., unstable or severe cardiac disease, liver disease, uncontrolled diabetes, kidney disease)

Patients enrolled into the study with Diabetic Peripheral Neuropathy, Complex Regional Pain Syndrome and Upper Limb pain are required to meet further inclusion/exclusion criteria in order to contribute to the analysis for that particular condition. These criteria are designed to ensure that the patient's condition aligns with the standard diagnostic criteria set by applicable clinical guidelines.

Painful Diabetic Peripheral Neuropathy (DPN) Inclusion Criteria

• Clinical diagnosis of diabetes mellitus according to the American Diabetes Association guidelines (ADA).
• Predominant pain condition being treated by SCS is lower-limb pain due to DPN
• Hemoglobin A1c (HbA1c) must be <8% within 6 months of enrollment for inclusion or have completed a preoperative risk assessment if >8%
• Presence of either numbness or at least one sensory disturbance (e.g., increased or decreased sensitivity, burning, pricking/stabbing, aching, "pins and needle" sensation) in the foot/feet.

Painful DPN Exclusion Criteria

• Lower-limb pain not associated with DPN or that cannot be distinguished from DPN (e.g., mononeuropathies, proximal neuropathies, nonneuropathic pain, peripheral vascular disease)
• History of lower-limb amputation or planned lower-limb amputations due to diabetes
• Large (≥3cm) and/or gangrenous ulcers or active infection of the lower limbs

Complex Regional Pain Syndrome (CRPS) Inclusion Criteria

• Meets diagnostic criteria for CRPS (International Association for the Study of Pain "Budapest Criteria")
• Disease that is clinically restricted to one hand or foot and affects the entire hand, foot or lower extremity
• CRPS is the predominant pain condition that SCS is intended to treat

CRPS Exclusion Criteria

• Presence of Reynaud's disease
• Current or previous neurologic abnormalities unrelated to CRPS
• Another condition affecting the function of the diseased or contralateral extremity
• Dystonia as a predominant component of their presentation

Upper Limb Pain (ULP) - non CRPS Inclusion Criteria

• Be diagnosed with radicular pain syndrome, or be diagnosed with radicular pain secondary to failed back surgery or herniated disk

ULP - non CRPS Exclusion Criteria

• Has significant cervical stenosis, as determined by the Investigator
• Failed treatments of carpal tunnel syndrome and/or cubital tunnel syndrome
• Has mechanical neck pain (e.g., facet spondylosis), as determined by the Investigator
• Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine
• Has brachial plexus injury as predominant cause of pain