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SenSight™
MEDTRONIC, INC. · Model B3400060 · UDI-DI 00763000426477
0
510(k) clearances
1,810
Adverse events (41 deaths)
4
Recalls
31
Facilities
Description
EXT B3400060 SENSIGHT NO MKR EMAN LJ53
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-08 | Boston Scientific Neuromodulation Corporation | Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) |
| 2025-07-08 | Boston Scientific Neuromodulation Corporation | Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stim |
| 2024-04-18 | Boston Scientific Neuromodulation Corporation | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead tr |
| 2019-04-24 | Boston Scientific Neuromodulation Corporation | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.