STEALTHSTATION S8 PREMIUM SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01316)
STEALTHSTATION S8 PREMIUM SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01316) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: STEALTHSTATION S8 PREMIUM SYSTEM; Generic name: INSTRUMENT, STEREOTAXIC; Manufacturer: MEDTRONIC NAVIGATION, INC.
| Device | STEALTHSTATION S8 PREMIUM SYSTEM |
|---|---|
| Generic name | INSTRUMENT, STEREOTAXIC |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Report number | 1723170-2020-01316 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THERE WERE NO COMPONENTS REPLACED. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. OTHER RELEVANT DEVICE(S) ARE: SW KIT 9735737 STEALTH S8 CRANIAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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