MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-06 for FUSION COMPACT 9735602 manufactured by Medtronic Navigation, Inc.
[178362990]
Other relevant device(s) are: product id: 9735638, version (b)(4). A system checkout was performed. It was confirmed that the electromagnetic localization box was not communicating with the system. Re-installing the system application software resolved the issue. The system then passed a system checkout. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178362991]
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that during a planned maintenance (pm), the electromagnetic localization box was having issues connecting to the navigation system. The manufacturing representative rebooted the system and electromagnetic localization box while disconnected, then powered both systems on separately, and once both were up and the navigation system was fully on, the communication cable connected. The electromagnetic box was then connected and read a 7, but then the emitter started intermittently powering on or remaining off. Additionally, only about half the time when the navigation system was booted up would the electromagnetic interface launch. At those times, the electromagnetic localization box read an 8 in the back box. Troubleshooting was performed by reloading the software on the system. After doing this and rebooting the system multiple times, there were no more issues. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00395 |
| MDR Report Key | 9678014 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Model Number | 9735602 |
| Catalog Number | 9735602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-06 |