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 2020-02-06 for FUSION? ENT NAVIGATION SYSTEM 9733560XOM manufactured by Medtronic Navigation, Inc.
[178362295]
Other relevant device(s) are:product id: 9733467 software version: (b)(4). A manufacturer representative went to the site to test the equipment. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional with no issues. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178362296]
Medtronic received information regarding a fusion system used during a functional endoscopic sinus surgery (fess) procedure. It was reported that during a case two nights ago. When navigating in the maxillary instrument displayed in the orbit. Navigation was aborted. Trouble shooting was done. The clinical specialist was on site to perform a system checkout, suspect due to poor registration quality. No additional information available at this time. There was a delay of less than 1 hour. No patient impact was correlated with this event. 2020-feb-06: new information received: the clinical specialist did not have additional information about the case. The surgeon aborted navigation because he questioned accuracy. The amount of inaccuracy is small, the clinical specialist believe it was due to poor registration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00397 |
| MDR Report Key | 9678241 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2012-08-21 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Model Number | 9733560XOM |
| Catalog Number | 9733560XOM |
| Device Expiration Date | 2013-07-17 |
| 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 | 2020-02-06 |