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 2020-01-30 for FUSION? ENT NAVIGATION SYSTEM 9733560XOM manufactured by Medtronic Navigation, Inc.
[178628266]
Other relevant device(s) are: product id: 9733467, serial/lot #: (b)(4). A medtronic representative went to the site to test the equipment. It was reported that no part of the navigation system was replaced. The hardware, software, 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
[178628267]
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess) procedure. During the registration, a "scan was missing a substantial piece of the forehead. " the was no metal interference when the emitter details were checked. The surgeon reportedly tried to register the patient 5 times unsuccessfully, and then moved forward without navigation. The manufacturer representative spoke with the surgeon about scan quality and requirements for the scan. The issue resulted in less than one hour procedure delay. There was no impact on patient outcome. 2020-jan-14 additional information was reported. It was reported that no registration data was present since navigation was aborted. As mentioned, a substantial amount of the forehead was missing which likely contributed to registration issues. Unable to provide further feedback at this time without seeing the trace pattern the site done. Will follow up with the local team to train the site on proper imaging protocol and trace pattern. 2020-jan-14 it was confirmed that the procedure was completed without navigation but imaging was not aborted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00304 |
| MDR Report Key | 9648868 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2011-01-25 |
| Date Added to Maude | 2020-01-30 |
| 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 | INSTRUMENT, STEREOTAXIC |
| Product Code | PGW |
| Date Received | 2020-01-30 |
| Model Number | 9733560XOM |
| Catalog Number | 9733560XOM |
| Device Expiration Date | 2018-12-31 |
| 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 | 2020-01-30 |