# K062041: Model 3875 1 X 8 SC Test Stimulation Lead

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Aug 16, 2006 after 28 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic Model 3873 1 x 8 Test Stimulation Lead: named in the summary without a submission number
- (no number) Medtronic Model 3874 1 x 8 Compact Test Stimulation Lead: named in the summary without a submission number

## Indications for use
The Model 3875 1 x 8 SC Test Stimulation Lead is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: * Failed Back Syndrome or Low Back Syndrome or Failed Back; * Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome; * Post Laminectomy Pain; * Unsuccessful Disk Surgery; * Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and surgical interventions; * Peripheral Causalgia; * Epidural Fibrosis; * Arachnoiditis or Lumbar Adhesive Arachnoiditis; * Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and, * Multiple Back Surgeries Additional Contraindication: The Medtronic Model 3875 1 x 8 SC Test Stimulation Lead is contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.

Source page: https://510kreport.com/device/K062041
Methodology: https://510kreport.com/methodology