Implantable Neurostimulator
Received Jul 31, 2026 · Event occurred Jul 1, 2020
Report 2182207-2026-02127 · MDR key 50100880
Device
Generic name
Stimulator, Spinal-cord, Totally Implanted For
Manufacturer
Medtronic NeuromodulationModel number
NEU_INS_STIMULATORCatalog number
NEU_INS_STIMULATOR
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Pain
Narrative
Description of Event or Problem
Information was received regarding a patient who was implanted with an implantable neurostimulator (INS) for unknown indications for use. It was reported that the patient had a replacement of the epidural neurostimulator and developed an infection causing pain.
Additional Manufacturer Narrative
G2. Foreign: FR. Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.