MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for FUSION COMPACT 9735602 manufactured by Medtronic Navigation, Inc.
[184911566]
No patient information provided as no patient was involved in this concern. The unique identifier was not available at the time of the event. No parts have been received by the manufacturer for evaluation. The manufacturer date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184911567]
Medtronic received information regarding a navigation system. It was reported outside of a procedure that upon boot up the system was displaying that localizer was disconnected. The emitter box displayed 7, and emitter was not chirping. Troubleshooting included technical services walking through recommended boot sequence. Computer booted up first, emitter booted up separately then re-establishing communication with usb connection. Additionally try booting up while connected. The issue did not resolve, still reflected as amber line of communication and localizer not connected. The site stated that there was a report of a power outage over the weekend. No patient was present at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01061 |
| MDR Report Key | 9879632 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUSION COMPACT |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-03-25 |
| Model Number | 9735602 |
| Catalog Number | 9735602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |