MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for O-ARM 1000 IMAGING SYSTEM BI70000020 manufactured by Medtronic Navigation, Inc (littleton).
[182615268]
Patient information was unavailable from the site. (b)(6). A medtronic representative went to the site to test the equipment. Testing revealed that the issue was resolved after tightening the nuts along with the spring on the close back cable. The imaging system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182615269]
Medtronic received information regarding an imaging device being used intra/peri-operatively of a sacroiliac and thoracolumbar procedure. It was reported that 1 of the nut has fallen off from the system when closing the gantry when taking patient exams. The exams were taken successfully, however, the gantry door was unable to be opened. The site attempted to open the gantry through "override" and tried to manually open the door without resolution. It was noted that the door cable was displaced from its original position. The case was completed without using the imaging system, but the site had to move the system to the patient's cranial side to continue the case. The site had to disassemble the surgical bed after the case to remove it from being stuck by the imaging system. There was a 30-minute delay in the procedure and there were no impact on patient outcome. It was later noted through additional follow-up, that this issue occurred during the post-operative images and the images were able to be used as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00341 |
| MDR Report Key | 9806920 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2010-03-16 |
| 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 | BI70000020 |
| Catalog Number | BI70000020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |