BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 3190998 · Received June 21, 2013

    Report

    Report Number
    2648612-2013-00027
    Event Type
    Death
    Date Received
    June 21, 2013
    Date of Event
    June 6, 2011
    Report Date
    June 4, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED TWO WEEKS POST IMPLANT WITH VOLUME OVERLOAD, MODERATE CHF, AND BIPEDAL EDEMA. THE VALVE WAS EXPLANTED AND REPLACED WITH A LARGER 31MM SJM MASTERS SERIES VALVE, BUT THE PT EXPIRED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283183 SJM MASTERS SERIES MECHANICAL HEART VALVE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL 29MJ-501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H| R