FDA Adverse Event
Injury
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
MDR report key: 1060269
·
Received June 10, 2008
Report
- Report Number
- 6000002-2008-07516
- Event Type
- Injury
- Date Received
- June 10, 2008
- Date of Event
- April 10, 2008
- Report Date
- May 13, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K923367
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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 APPROX AFTER AN IMPLANT DURATION OF 38 MONTHS, DUE TO UNK REASONS. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COSGROVE-EDWARDS ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4600 | 4K1626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |