FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1242327
·
Received November 20, 2008
Report
- Report Number
- 6000002-2008-09318
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 28, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION WAS NOT COMPLETE AT THE TIME OF SUBMISSION OF THIS INITIAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 12 YEARS DUE TO UNKNOWN REASONS. THE DEVICE MODEL AND SERIAL NUMBER WERE NOT REPORTED. NO OTHER DETAILS CONCERNING THE EVENT WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | HVTUNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |