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 2020-03-26 for BASE SYS BI70002000 O-ARM SYS O2 manufactured by Medtronic Navigation, Inc (littleton).
[185037831]
Other relevant device(s) are: product id: bi71000218, serial/lot #: (b)(4). Product id: bi71000568, serial/lot #: (b)(4). A manufacturer representative went to the site to test the imaging system. Hardware parts were replaced which resolved the issue. The left side tracker was flicking at all distances. Changed tracker and calibrated left side. The imaging system passed all tests and performed as intended. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185037832]
Medtronic received information regarding an imaging system used during a cervical spine procedure. It was reported that the imaging system trackers were blinking and they want a system checkout. There was no delay to the case and no patient impact. On 2020-mar-11 (rep) new information received: the tracker i replaced was within calibration. The new one needed to be calibrated because it? S required when you replace it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00414 |
| MDR Report Key | 9883465 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2018-03-14 |
| Date Added to Maude | 2020-03-26 |
| 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 | BASE SYS BI70002000 O-ARM SYS O2 |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-26 |
| Model Number | BI70002000 |
| Catalog Number | BI70002000 |
| 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 | 2020-03-26 |