BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM EPIC SUPRA TISSUE VALVE

    MDR report key: 1213043 · Received October 24, 2008

    Report

    Report Number
    3001743903-2008-00055
    Event Type
    Death
    Date Received
    October 24, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO ENDOCARDITIS (BY STREPTOCOCCUS AGALACTIAE) AND REPLACED WITH ANOTHER BIOPROSTHESIS (MODEL AND SERIAL NUMBER UNK). IN 2008, THE PT EXPIRED DUE TO MULTI-ORGAN FAILURE. AN AUTOPSY WAS NOT PERFORMED, AND ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC SUPRA TISSUE VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. ESP-21

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R