BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 6094496 · Received November 10, 2016

    Report

    Report Number
    2938836-2016-14043
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    July 17, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746035 FORTIFY ASSURA DR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2357-40C A000014020

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death (B)(4)| (B)(4)