S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM Adverse Event — Injury (MDR 1723170-2020-01317)
S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM Adverse Event — Injury (MDR 1723170-2020-01317) 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 | 1723170-2020-01317 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE PRECISION AIMING DEVICE WAS FOUND TO BE MALFUNCTIONING AS THE REPORTED ISSUE COULD BE REPLICATED AND THAT THE PASSIVE PLANAR PROBE AND VERTEK PROBE WERE ACCURATE ON KNOWN ANATOMICAL LANDMARKS. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. CONCOMITANT MEDICAL PRODUCTS: OTH |
| Source | openFDA MAUDE (device adverse events) |
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