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 2020-03-25 for O-ARM O2 IMAGING SYSTEM BI70002000 manufactured by Medtronic Navigation, Inc (littleton).
[184914255]
No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184914256]
Medtronic received information regarding an imaging device being used intra/peri-operatively of a sacroiliac and thoracolumbar procedure. It was reported that the site took 2 spins and believed that both had been transferred to the navigation system, but found that only the 1st spin had been transferred. The site brought back the imaging system back into the room and attempted to transfer the scan, but were unable to. It was later noted that the issue was due the 2nd spin having no nav tag. There was a less than 1-hour delay to the procedure and no impact on patient outcome. Additional follow-up determined that the site completed the procedure without the use of navigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00410 |
| MDR Report Key | 9879221 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-03-14 |
| Date Added to Maude | 2020-03-25 |
| 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 (LITTLETON) |
| Manufacturer Street | 300 FOSTER ST |
| Manufacturer City | LITTLETON MA 01460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | O-ARM O2 IMAGING SYSTEM |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-25 |
| Model Number | BI70002000 |
| Catalog Number | BI70002000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Address | 300 FOSTER ST LITTLETON MA 01460 US 01460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |