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 2020-03-25 for FUSION COMPACT 9735602 manufactured by Medtronic Navigation, Inc.
[184917188]
Other relevant device(s) are: product id: 9735634, serial/lot #: (b)(4). The power supply was returned to the manufacturer for analysis. The returned power supply had normal output when connected to ac. No problem found. A medtronic representative went to the site to test the equipment. It was reported that the power supply of the navigation system was replaced and the software was uninstalled/re-installed. The hardware and instruments passed the system checkout. The system was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184917189]
Medtronic received information regarding a navigation system that was used during a functional endoscopic sinus surgery (fess) procedure. It was reported that the system shut down unexpectedly during the procedure. There was a reported delay of less than one hour. There is no known impact on patient outcome. On 2020-mar-05 additional information received. It was reported that while on site to troubleshoot, the manufacturer representative could not replicate the issue. Software was uninstalled/reinstalled. Per site, the system will randomly shut down while plugged in and have to boot it up. The other navigation system at this site is used in the same operating room and does not have the same behavior. Probable cause of the issue was determine to be faulty power supply. On (b)(6) 2020 it was reported that after the site restarted the system, they were able to use it to complete the process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01058 |
| MDR Report Key | 9878585 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| 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 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 9735602 |
| Catalog Number | 9735602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-25 |