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 2020-03-10 for FUSION? ENT NAVIGATION SYSTEM 9733560XOM manufactured by Medtronic Navigation, Inc.
[187925015]
Concomitant medical products: product id: 9733361, serial/lot #: unknown, ubd: unknown, udi#: unknown. An update was provided that the site biomed took the side panel off and found the power cord was disconnected from the isolation transformer. The biomed reconnected the cable and the issue resolved. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187925016]
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess). It was reported that intra-operatively, the system unexpectedly powered itself off. The site tried to power it back on and tried other known outlets with no resolution. When the site flipped the power switch, not even the light in the power switch came on. Conflicting information was received that the procedure was completed without the navigation system and that the surgery was rescheduled. Clarification was received that the case was aborted midway through the procedure and after anesthesia had been administered. There was no reported impact to patient outcome and there was no reported delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00837 |
| MDR Report Key | 9813715 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2015-06-09 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-10 |
| Model Number | 9733560XOM |
| Catalog Number | 9733560XOM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2020-03-10 |