BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 3190047 · Received June 21, 2013

    Report

    Report Number
    2648612-2013-00030
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EIGHT HOURS POSTOPERATIVELY, THE PT'S APPEARED TO BE IN HEART FAILURE WITH BLOOD PRESSURE INSTABILITY. THE PT LEFT THE HOSPITAL THE NEXT MORNING AGAINST MEDICAL ADVICE AND DIED LATER THAT DAY. THE CAUSE OF DEATH WAS REPORTED TO BE UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283792 SJM MASTERS SERIES MECHANICAL HEART VALVE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC 25MJ-501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H