MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for REOCOR D - EXTERNAL PACEMAKER manufactured by Biotronik, Inc..
[121501775]
Patient was being taken off the bypass machine and team was trying to get the heart started again. Pacing wires were inserted in the heart and connected to the biotronic pacing cables and paced with the biotronic pacing box. Both the surgeon and the anesthesiologist have been doing this for many years. The pacing didn't work with the first set of cables and box. Team changed out the cables, that didn't work. Team next changed out the box? That didn't work either. The team moved the actual pacing wires on the heart to make sure they were in a good place? That didn't work. The cables were changed out again? Still didn't work. The team again changed out the box? Again, didn't work. After a third unsuccessful try of changing everything, another manufacturer pacer and cables were requested. Everything was changed out one more time while we were waiting for these to arrive - third try again didn't work. Once the other manufacturer pacer arrived, we hooked it up and it immediately started pacing. This needs to be discussed and a solution put in place for the safety of the patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7901468 |
| MDR Report Key | 7901468 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-06-01 |
| Report Date | 2018-09-05 |
| Date Reported to FDA | 2018-09-05 |
| Date Reported to Mfgr | 2018-09-24 |
| Date Added to Maude | 2018-09-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REOCOR D - EXTERNAL PACEMAKER |
| Generic Name | PULSE GENERATOR, EXTERNAL PACEMAKER, DUAL CHAMBER |
| Product Code | OVJ |
| Date Received | 2018-09-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK, INC. |
| Manufacturer Address | 6024 JEAN ROAD LAKE OSWEGO OR 97035 US 97035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-24 |