FDA Adverse Event
Death
Summary report: N
SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
MDR report key: 1651058
·
Received April 2, 2010
Report
- Report Number
- 2648612-2010-00025
- Event Type
- Death
- Date Received
- April 2, 2010
- Report Date
- April 2, 2010
- Manufacturer
- ST. JUDE MEDICAL, PUERTO RICO INC. (CS)
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED, AN SJM 17 MM MECHANICAL VALVE (MEDWATCH REPORT# 2648612-2010-00024) WAS EXPLANTED APPROXIMATELY ONE MONTH AND A HALF POST-OPERATIVELY DUE TO THROMBOSIS. THIS VALVE WAS THEN IMPLANTED AND WITHIN A MONTH OR TWO, IT THROMBOSED AND THE PT DIED (DATE UNK). ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE | ROTATABLE HEART VALVE | LWQ | ST. JUDE MEDICAL, PUERTO RICO INC. (CS) | 17MHPJ-505 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |