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 2020-03-09 for O-ARM 1000 IMAGING SYSTEM 9732719 manufactured by Medtronic Navigation, Inc (littleton).
[183280834]
Device evaluation has not been done at the time of submitting this report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183280835]
Medtronic received information regarding an imaging system used during a sacroiliac and thoracolumbar procedure. It was reported that they felt inaccurate. When navigating on the navigation system, they felt they were "too deep" when they should have been more superficial (length was unknown). They took another spin and felt they were still inaccurate and confirmed this by taking an ap and lateral shot using a different system, they proceeded with the case by switching out the reference frame and the system. There was a procedure delay of one hour or longer and no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00339 |
| MDR Report Key | 9806156 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-09 |
| 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 1000 IMAGING SYSTEM |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-09 |
| Model Number | 9732719 |
| Catalog Number | 9732719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-09 |