FDA Adverse Event
Death
Summary report: N
NONE
MDR report key: 1013160
·
Received March 14, 2008
Report
- Report Number
- 6000002-2008-06205
- Event Type
- Death
- Date Received
- March 14, 2008
- Date of Event
- February 4, 2008
- Report Date
- February 18, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED IN 2008. REPORTEDLY, THE DEVICE WAS IMPLANTED 4 DAYS PRIOR. IT IS UNKNOWN IF THE PT'S DEATH WAS ATTRIBUTED TO THE DEVICE, AS NO OTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | LWR | EDWARDS LIFESCIENCES | 6900P25MM | 329041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death| R |