FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
MDR report key: 1051812
·
Received May 22, 2008
Report
- Report Number
- 6000002-2008-07289
- Event Type
- Death
- Date Received
- May 22, 2008
- Date of Event
- December 19, 2007
- Report Date
- January 23, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, PATIENT EXPIRED APPROXIMATELY AFTER AN IMPLANT DURATION OF 0 DAYS, DUE TO UNKNOWN REASONS. PHYSICIAN STATED DURING A FOLLOW UP THAT THE DEATH IS NOT DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2800 | R07F1270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |