S7 STEALTHSTATION NAVIGATION SYSTEM Adverse Event — Injury (MDR 1723170-2020-01318)
S7 STEALTHSTATION NAVIGATION SYSTEM Adverse Event — Injury (MDR 1723170-2020-01318) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: S7 STEALTHSTATION NAVIGATION SYSTEM; Generic name: INSTRUMENT, STEREOTAXIC; Manufacturer: MEDTRONIC NAVIGATION, INC.
| Device | S7 STEALTHSTATION NAVIGATION SYSTEM |
|---|---|
| Generic name | INSTRUMENT, STEREOTAXIC |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Report number | 1723170-2020-01318 |
| 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 NAVIGATION SYSTEM FUNCTIONED AS DESIGNED AND THE REPORTED IMPRECISION 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: 9733763, SERIAL/LOT #: UNK. IF INFORMATION IS PROVIDED IN T |
| Source | openFDA MAUDE (device adverse events) |
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