BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY DR, U1.6 SJ4 US

    MDR report key: 6135021 · Received November 30, 2016

    Report

    Report Number
    2938836-2016-14782
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    August 14, 2016
    Report Date
    October 20, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVZ
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AFTER THE PATIENT WAS REPORTED TO HAVE DECEASED. AUTOMATED TEST EQUIPMENT (ATE) TESTING WAS PERFORMED, AND THE DEVICE WAS NORMAL. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 HEART DISEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785177 FORTIFY DR, U1.6 SJ4 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2231-40Q 3183630

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death 1888TC/52, BCG43389| 7120Q/58, BJP25742| 1888TC/52, BCG43389| 7120Q/58, BJP25742