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 2020-01-21 for SYSTEM 9733560 FUSION EM manufactured by Medtronic Navigation, Inc.
[183920610]
Other relevant device(s) are:product id: 9733467 software version: (b)(4). No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183920611]
Medtronic received information regarding a fusion system used during a functional endoscopic sinus surgery (fess) procedure. It was reported that before a case with the surgeon, when selecting the patient scans, the monitor went black and the reboot splash screen appeared. However, after approximately 5 minutes the splash screen did not clear nor did it proceed forward. A medtronic representative rebooted the system and it functioned normally. There was a delay of less than 1 hour. No patient impact was correlated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00193 |
| MDR Report Key | 9610944 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-21 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2015-09-11 |
| Date Added to Maude | 2020-01-21 |
| 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 | SYSTEM 9733560 FUSION EM |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-01-21 |
| Model Number | 9733560 |
| Catalog Number | 9733560 |
| Lot Number | N06188760 |
| 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 | 2020-01-21 |