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SureScan™
InterStim™ SureScan™
MEDTRONIC, INC. · Model 978A133 · UDI-DI 00763000596835
0
510(k) clearances
82,553
Adverse events (80 deaths)
9
Recalls
21
Facilities
Description
LEAD 978A133 ISTM SSMRI 2.16MM EMAN GLBL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-03 | Medtronic Neuromodulation | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause |
| 2024-06-17 | Medtronic Neuromodulation | A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. |
| 2023-07-06 | Medtronic Neuromodulation | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. |
| 2022-02-28 | Medtronic Neuromodulation | There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" |
| 2021-11-04 | Medtronic Neuromodulation | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not fo |
| 2019-05-15 | Medtronic Neuromodulation | There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer). |
| 2008-05-12 | Medtronic Neuromodulation | Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchr |
| 2007-06-25 | Medtronic Neuromodulation | Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Mod |
| 2007-06-25 | Medtronic Neuromodulation | A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Progr |
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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.