FDA Adverse Event
Other
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
MDR report key: 1030836
·
Received April 17, 2008
Report
- Report Number
- 6000002-2008-06548
- Event Type
- Other
- Date Received
- April 17, 2008
- Date of Event
- February 19, 2008
- Report Date
- March 24, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 AFTER AN IMPLANT DURATION OF 128 MONTHS DUE TO AN UNK REASON. NO OTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COSGROVE-EDWARDS ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4600 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |