NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01304)
NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01304) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM; Generic name: INSTRUMENT, STEREOTAXIC; Manufacturer: MEDTRONIC NAVIGATION, INC.
| Device | NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM |
|---|---|
| Generic name | INSTRUMENT, STEREOTAXIC |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Report number | 1723170-2020-01304 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE ISSUE COULD NOT BE REPLICATED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID #: 9735737, SOFTWARE VERSION #: 1.2.0. IF INFORMATION IS PROVIDED IN THE |
| Source | openFDA MAUDE (device adverse events) |
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