BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY QUADRA CRT-D, OUS MODEL, DF1COMP

    MDR report key: 6197151 · Received December 21, 2016

    Report

    Report Number
    2938836-2016-19979
    Event Type
    Death
    Date Received
    December 21, 2016
    Report Date
    December 20, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE PATIENT WAS FOUND DEAD DUE TO SUSPECTED SUDDEN CARDIAC DEATH. IT IS UNKNOWN IF THE DEATH IS RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845666 UNIFY QUADRA CRT-D, OUS MODEL, DF1COMP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3251-40 3613709

    Patients

    Seq Age Sex Outcome Treatment
    1 Death