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 2020-03-31 for S7 9733856 manufactured by Medtronic Navigation, Inc.
[185950066]
The system was serviced and passed all tests and was performing as intended. Troubleshooting was done outside of the system service. The software reinstalled and the issue could not be replicated after the software was installed suggesting this was likely a software issue. Software logs have been received but analysis has not been done at this time. Other relevant device(s) are: software: synergy spine s7; i7 (b)(4), 9733686, software version: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185950067]
Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure. It was reported that after verifying the instruments and taking an imaging spin, the site was unable to see the cad model of the instruments being used when navigating. The scan would move when moving the instruments in view of the camera, but the cad models could not be seen. Trajectory 1 and 2 did not display the instruments and the cross-hairs did not affect the behavior either. It was unclear if the site had the cross-hairs on or off or which views were being used. There was no impact on patient outcome. It was reported that there was a procedure delay of less than one hour. The procedure was completed by bringing in a new navigation system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01109 |
| MDR Report Key | 9903232 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2012-11-08 |
| 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 | S7 |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-27 |
| Model Number | 9733856 |
| Catalog Number | 9733856 |
| Device Expiration Date | 2014-03-28 |
| 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 |