MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for 9734056 manufactured by Medtronic Navigation, Inc.
[145354046]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[145354047]
Medtronic received information regarding a navigation system being during a sacroiliac and thoracolumbar procedure. It was reported that the site's cross hair stationary was used, but probe in the trajectory was shown obliquely. The procedure was completed using the navigation with no patient injury. It occurred intra/peri-operatively with no delay to surgical time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2019-02362 |
| MDR Report Key | 8611337 |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2017-07-06 |
| Date Mfgr Received | 2017-07-06 |
| Date Added to Maude | 2019-05-15 |
| 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 | 2019-05-15 |
| Model Number | 9734056 |
| Catalog Number | 9734056 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-05-15 |