FDA Adverse Event
Injury
Summary report: N
SJM MECHANICAL HEART VALVE
MDR report key: 1180475
·
Received September 26, 2008
Report
- Report Number
- 2126673-2008-00004
- Event Type
- Injury
- Date Received
- September 26, 2008
- Date of Event
- June 25, 2008
- Report Date
- September 26, 2008
- Manufacturer
- ST. JUDE MEDICAL, INC (CS-LILLEHEI)
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO REGURGITATION. DURING THE EXPLANT PROCEDURE, ONE LEAFLET WAS BROKEN INTO THREE PIECES. THE SURGEON RECOVERED ALL THE PIECES AND IMPLANTED ANOTHER VALVE (MODEL AND SN UNK). ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM MECHANICAL HEART VALVE | STANDARD HEART VALVE | LWR | ST. JUDE MEDICAL, INC (CS-LILLEHEI) | 23A-101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |