FDA Adverse Event
Death
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
MDR report key: 1080828
·
Received July 21, 2008
Report
- Report Number
- 6000002-2008-08121
- Event Type
- Death
- Date Received
- July 21, 2008
- Date of Event
- June 3, 2008
- Report Date
- July 8, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K923367
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFR REPORT # FOR OTHER DEVICE PATIENT HAD IMPLANTED: 6000002-2008-08123. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAS EXPIRED AFTER AN IMPLANT DURATION OF 4 DAYS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. PT ALSO HAD A 3000TFX IMPLANTED ON THE SAME DAY IN THE ATRIAL POSITION. 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 | R-07H1603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |