FDA Adverse Event
Injury
Summary report: N
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
MDR report key: 1233853
·
Received November 12, 2008
Report
- Report Number
- 6000002-2008-09264
- Event Type
- Injury
- Date Received
- November 12, 2008
- Date of Event
- February 7, 2008
- Report Date
- October 28, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P000007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS | REPLACMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2500P | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |