FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
MDR report key: 1040567
·
Received May 9, 2008
Report
- Report Number
- 6000002-2008-07145
- Event Type
- Death
- Date Received
- May 9, 2008
- Date of Event
- December 13, 2007
- Report Date
- April 10, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF SEVEN MONTHS, DUE TO UNKNOWN REASONS. UNKNOWN IF THE DEVICE WAS EXPLANTED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4400 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Death |