BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA STENTED TISSUE VALVE

    MDR report key: 2926369 · Received January 16, 2013

    Report

    Report Number
    3009024882-2013-00001
    Event Type
    Injury
    Date Received
    January 16, 2013
    Report Date
    December 18, 2012
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA. (CS)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT VALVE REPLACEMENT SURGERY WITH THIS SJM TRIFECTA VALVE. THE VALVE WAS LATER EXPLANTED DUE TO ENDOCARDITIS AND REPLACED WITH AN BIOPROSTHESIS FROM ANOTHER MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24643 SJM TRIFECTA STENTED TISSUE VALVE NONE LWR ST. JUDE MEDICAL, COSTA RICA LTDA. (CS) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R