MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-09 for FIBRILLATING DEVICE UNK manufactured by Unk.
[15250400]
Pt was admitted for cardiac catheterization on 10/22/96. Pt underwent surgery on 10/23/96 for mitral valve replacement using a right thoracotomy approach. The heart was fibrillated during the initial surical procedure for approx 3 1/2 hrs. At the conclusion of fibillation pt developed poor left ventricular function that necessitated placement of a bilateral ventricular assistive device. On future review, there was a question whether the fibrillating device contributed to the surgery due to cardiac tamponade. The pt expired 10/26/96. Autopsy report revealed: massive circumferential myocardial infarction involving base of left ventricle without significant coronary artery disease. Bilateral pulmonary passive congestion, edema and early pneumonitis. Microemphysema, moderate passive congestion of liver, bilateral mild chronic pyelonephritis, soft tissue edema, status postoperative: porcine mitral valve replacement, biventricular assist device placement, mediastinotomy for evacuation of pericardial blood clot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 83748 |
| MDR Report Key | 83748 |
| Date Received | 1997-04-09 |
| Date of Report | 1997-04-01 |
| Date of Event | 1996-10-26 |
| Date Facility Aware | 1997-03-04 |
| Report Date | 1997-04-04 |
| Date Reported to FDA | 1997-04-04 |
| Date Added to Maude | 1997-04-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBRILLATING DEVICE |
| Generic Name | FIBRILLATING DEVICE |
| Product Code | LIW |
| Date Received | 1997-04-09 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 83052 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-04-09 |