FUSION¿ ENT NAVIGATION SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01303)
FUSION¿ ENT NAVIGATION SYSTEM Adverse Event — Malfunction (MDR 1723170-2020-01303) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FUSION¿ ENT NAVIGATION SYSTEM; Generic name: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT; Manufacturer: MEDTRONIC NAVIGATION, INC.
| Device | FUSION¿ ENT NAVIGATION SYSTEM |
|---|---|
| Generic name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Report number | 1723170-2020-01303 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9731203, SERIAL/LOT #: (B)(4), UDI#: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECK OUT AND THEY REPLACED THE EMITTER. THE SYSTEM FUNCTIONED AS INTENDED. FDM10, FDR120, FDC4307 ARE APPLICABLE TO THE SYSTEM CHECKOUT. THE ELECTROMAGNETIC FIELD GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS. THE REPORT |
| Source | openFDA MAUDE (device adverse events) |
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