FDA Adverse Event
Injury
Summary report: N
REPLACEMENT HEART VALVE
MDR report key: 1202987
·
Received October 16, 2008
Report
- Report Number
- 6000002-2008-08950
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 29, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, THE DEVICE WAS EXPLANTED AT IMPLANT AND REPLACED BY A 6900P DUE TO UNK REASONS. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED (DISCARDED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLACEMENT HEART VALVE | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | LWR | EDWARDS LIFESCIENCES | 6900P | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |