BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY ASSURA VR ICD, US

    MDR report key: 6205168 · Received December 27, 2016

    Report

    Report Number
    2938836-2016-19015
    Event Type
    Death
    Date Received
    December 27, 2016
    Report Date
    April 28, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. THE DEVICE WAS INTERROGATED WITH A PROGRAMMER AND HAD NOT REACHED ERI. THE DEVICE WAS TESTED USING AUTOMATED TESTING EQUIPMENT AND 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 CARDIAC ARREST, FATAL ARRHYTHMIA. 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
    857685 FORTIFY ASSURA VR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1357-40Q 4888869

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)