MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-16 for FUSION? ENT NAVIGATION SYSTEM 9735704R manufactured by Medtronic Navigation, Inc.
[184348791]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184348792]
Medtronic received information regarding a navigation system being used outside of a procedure. There was no patient involvement. After loading model exams, the images were pixelated. When the manufacturer representative entered the "edit 3d model task", the software restarted. The site did not have any other images to test on the system. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00169 |
| MDR Report Key | 9596514 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-16 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2017-12-19 |
| Date Added to Maude | 2020-01-16 |
| 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? ENT NAVIGATION SYSTEM |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-01-16 |
| Model Number | 9735704R |
| Catalog Number | 9735704R |
| Lot Number | 1795705 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-16 |