MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-11 for FUSION COMPACT NAVIGATION SYSTEM 9735602 manufactured by Medtronic Navigation, Inc.
[183793176]
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. Testing revealed that an electromagnetic communication cable was replaced. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183793177]
Medtronic received information that, while in a functional endoscopic sinus surgery (fess), the navigation system displayed that the electromagnetic navigation interface was not communicating with the system. It was reported that the issue occurred pre-operatively. The user disconnected the universal serial bus (usb) cable, rebooted the navigation system which did not restore functionality. The surgeon opted to complete the procedure without the use of the navigation system. There was no reported impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00460 |
| MDR Report Key | 9695884 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-11 |
| 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 NAVIGATION SYSTEM |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-02-11 |
| 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 | 2020-02-11 |