FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS BIOPROSTHESIS
MDR report key: 1233264
·
Received November 13, 2008
Report
- Report Number
- 6000002-2008-09284
- Event Type
- Death
- Date Received
- November 13, 2008
- Report Date
- October 29, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P870056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAS EXPIRED. THE DATE OF PT'S DEATH AND IMPLANT DURATION ARE UNK. IT IS UNK IF THE DEATH WAS DEVICE RELATED. PT ALSO HAD TWO OTHER DEVICES IMPLANTED, PLEASE REFERENCE MFR#6000002-2008-08979 AND MFR#6000002-2008-09282. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 6625 | R08F1334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |