FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS BIOPROSTHESIS
MDR report key: 1081851
·
Received July 22, 2008
Report
- Report Number
- 6000002-2008-08148
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- December 19, 2007
- Report Date
- January 14, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P870056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED IN LATE 2007 AFTER 63 DAYS OF IMPLANT DURATION, DUE TO UNK REASONS. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #2700, WAS EXPLANTED. REFER TO MFR# 6000002-2008-08146. 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 | 5D0635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |