BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY ST DR, U1.6 SJ4 ID

    MDR report key: 6136369 · Received November 30, 2016

    Report

    Report Number
    2938836-2016-14820
    Event Type
    Death
    Date Received
    November 30, 2016
    Report Date
    November 4, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S FAMILY THAT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785274 FORTIFY ST DR, U1.6 SJ4 ID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2235-40Q 3822616

    Patients

    Seq Age Sex Outcome Treatment
    1 Death