S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01308)
S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01308) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM; Generic name: INSTRUMENT, STEREOTAXIC; Manufacturer: MEDTRONIC NAVIGATION, INC.
| Device | S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM |
|---|---|
| Generic name | INSTRUMENT, STEREOTAXIC |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Report number | 1723170-2020-01308 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE EMITTER WAS REPLACED TO RESTORE FUNCTIONALITY. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE EMITTER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT THE LEMO NUT WAS LOOSE. |
| Source | openFDA MAUDE (device adverse events) |
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