BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY ST DR

    MDR report key: 6170182 · Received December 13, 2016

    Report

    Report Number
    2938836-2016-16127
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    July 22, 2016
    Report Date
    May 11, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH USING AUTOMATED TESTING EQUIPMENT, AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE IS INCLUDED IN THE PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821994 FORTIFY ST DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2241-40Q 3737809

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death 1999/46, BND022097| 7170Q/58, BKM016028