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 |