MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-25 for FUSION? ENT NAVIGATION SYSTEM 9733560XOM manufactured by Medtronic Navigation, Inc.
[183978926]
Udi not available for this system. Other relevant device(s) are: product id: 960-152, software version: 3. 17. During troubleshooting, the system was rebooted but the issue did not resolve. An attempt was made to import the exam again but the issue did not resolve. It was noted that the old patient exams had been cleared off the system and it had 99% free space. A medtronic representative went to the site to test the equipment. Testing revealed that the software was uninstall and reinstalled. After the software install, two separate patient discs were uploaded without issue. The system then passed the system checkout and was found to be fully functional. 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
[183978927]
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess). It was reported that intra-operatively, the site was loading a patient exam disc with unstructured option. After trying to load, it stated that no patients were available. Further information was received that the system did the full patient import process, but afterward the patient was not in the list of imported patients. The procedure was completed without the use of the navigation system and there was no reported impact to patient outcome. There was a reported delay to the procedure of thirty minutes due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00626 |
| MDR Report Key | 9749852 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-25 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-02-25 |
| 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? ENT NAVIGATION SYSTEM |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-02-25 |
| Model Number | 9733560XOM |
| Catalog Number | 9733560XOM |
| 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 | 2020-02-25 |