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 371300 manufactured by Biotronik, Inc..
[121516553]
Patient on cardiopulmonary bypass. Surgeon went through two pacing boxes, 3 pacing cables, and 2 pacing leads in order to get a paced rhythm. Resulted in patient being on cpb extra 10 minutes and extra stitch in the heart
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7901467 |
| MDR Report Key | 7901467 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-04-17 |
| 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 |
| Model Number | 371300 |
| Catalog Number | 371300 |
| 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 |