BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY VR, U1.6 SJ4 ID

    MDR report key: 6182789 · Received December 16, 2016

    Report

    Report Number
    2938836-2016-16405
    Event Type
    Death
    Date Received
    December 16, 2016
    Report Date
    December 8, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE PATIENT FOR FOLLOW UP AND WAS NOTIFIED THE PATIENT HAD EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. FURTHER INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831757 FORTIFY VR, U1.6 SJ4 ID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CD1233-40Q 3244229

    Patients

    Seq Age Sex Outcome Treatment
    1 Death