FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
MDR report key: 983949
·
Received January 21, 2008
Report
- Report Number
- 6000002-2008-05855
- Event Type
- Death
- Date Received
- January 21, 2008
- Date of Event
- November 13, 2007
- Report Date
- November 30, 2007
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, PT EXPIRED APPROXIMATELY AFTER AN IMPLANT DURATION OF 0.47 MONTHS (IN 2007, AFTER AN IMPLANT DATE OF THE MONTH BEFORE), DUE TO UNK REASONS. UNK IF PT DEATH IS DEVICE RELATED. INFO RECEIVED IN 2008: PT EXPIRED DUE TO HEART BLOCK. UNSURE IF PT'S DEATH IS DEVICE-RELATED. UNSURE IF DEVICE WAS EXPLANTED. INFO PER AMBER FROM THE SURGEON'S OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2800TFX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |