BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY ASSURA VR ICD, US

    MDR report key: 6828803 · Received August 29, 2017

    Report

    Report Number
    2017865-2017-31391
    Event Type
    Death
    Date Received
    August 29, 2017
    Date of Event
    August 1, 2017
    Report Date
    November 16, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE, HYPERTENSION, HYPERLIPIDEMIA, AND DIABETES MELLITUS 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607135 FORTIFY ASSURA VR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD1357-40Q 4154709

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death