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 2020-03-19 for MEDTRONIC NAVIGATION UNK_NAV_SYS manufactured by Medtronic Navigation, Inc.
[184072533]
Other relevant device(s) are: product id: 9660651r, serial/lot #: unknown. Unique device identifier (udi) is unavailable. Onsite functional and visual examination was performed by a manufacturer representative. Hardware parts were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. Device manufacture date is unavailable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184072534]
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess) procedure. It was reported that the axiem box had multiple ports that were not functioning. The site switched the instruments to different ports. The clinical specialist checked out the system and was able to replicate the port failures. There was a delay of less than 1 hour. No patient impact was correlated with this event. New information received: serial number is unknown: potential defective unit has already been shipped back to medtronic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00960 |
| MDR Report Key | 9853333 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-19 |
| 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 | MEDTRONIC NAVIGATION |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-19 |
| Model Number | UNK_NAV_SYS |
| Catalog Number | UNK_NAV_SYS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-19 |