MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for S8 PREMIUM 9735665 manufactured by Medtronic Navigation, Inc.
[185764023]
The system was serviced in the field and the camera was replaced. The system passed all tests. The camera was returned for analysis. The returned camera failed an accuracy test at 0. 32mm with a passing threshold of 0. 25mm. A check of the event log also showed intermittent firmware incompatibility and an illuminator current low message from october 2019. Other relevant device(s) are: camera refurb, 9735821r vega base s8 svc, lot number: p900522. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185764024]
No issue was alleged. Medtronic received information regarding a navigation system found during a planned maintenance. It was reported that the camera failed an aak test. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01113 |
| MDR Report Key | 9903917 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2017-03-02 |
| Date Added to Maude | 2020-03-31 |
| 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 | S8 PREMIUM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 9735665 |
| Catalog Number | 9735665 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-31 |