MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-19 for O-ARM IMAGING SYSTEM BI70000025120 manufactured by .
[127611941]
Patient information was unavailable from the site. Device has not been evaluated. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[127611942]
Medtronic received information regarding an imaging device being used for an electrode and probe placement procedure. It was reported that during the surgical implantation there was a malfunction that compelled the study team to abort the implantation and reschedule the surgery for (b)(6) 2013. This error occurred before any incision was made, but after the head frame was in place. The patient was described as inconvenienced, but uninjured and remained psychiatrically stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2018-00375 |
| MDR Report Key | 8084744 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2013-09-18 |
| Date Mfgr Received | 2015-09-15 |
| Device Manufacturer Date | 2011-12-06 |
| Date Added to Maude | 2018-11-19 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | O-ARM IMAGING SYSTEM |
| Product Code | OXO |
| Date Received | 2018-11-19 |
| Model Number | BI70000025120 |
| Catalog Number | BI70000025120 |
| Device Expiration Date | 1950-01-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Brand Name | O-ARM IMAGING SYSTEM |
| Product Code | IZL |
| Date Received | 2018-11-19 |
| Model Number | BI70000025120 |
| Catalog Number | BI70000025120 |
| Device Expiration Date | 1950-01-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-19 |