STEALTHSTATION S8 SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01309)
STEALTHSTATION S8 SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01309) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: STEALTHSTATION S8 SYSTEM; Generic name: INSTRUMENT, STEREOTAXIC; Manufacturer: MEDTRONIC NAVIGATION, INC.
| Device | STEALTHSTATION S8 SYSTEM |
|---|---|
| Generic name | INSTRUMENT, STEREOTAXIC |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Report number | 1723170-2020-01309 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVAN |
| Source | openFDA MAUDE (device adverse events) |
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