MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for 9734056 manufactured by Medtronic Navigation, Inc.
[131312198]
Patient information not available. Device information not available on the date of filing. No device/components were returned to the manufacturer on the date of filing. Manufacture date was not available on the date of filing. Pma/510(k) number was not available on the date of filing. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131312199]
Medtronic received information regarding a navigation system. It was reported that intra/peri-operatively during a cranial resection procedure, registration was performed with prone position in em for the craniotomy procedure of tumor excision, but the accuracy was unfavorable. Thus, restarting registration was attempted by pressing the antenna against another place, but both the antenna and the probe became unable to respond. The issue persisted despite rebooting. The orange error lamp lit up on the box of em. The issue was resolved by switching to optical. There was a delay to the procedure of less than one hour. There was no reported impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2018-06354 |
| MDR Report Key | 8180874 |
| Date Received | 2018-12-19 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-12-26 |
| Date Added to Maude | 2018-12-19 |
| 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 | 0 |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | ORR |
| Date Received | 2018-12-19 |
| Returned To Mfg | 2018-12-28 |
| Model Number | 9734056 |
| Catalog Number | 9734056 |
| 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 | 2018-12-19 |