BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4210691 · Received October 29, 2014

    Report

    Report Number
    2938836-2014-17233
    Event Type
    Death
    Date Received
    October 29, 2014
    Date of Event
    September 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE HOSPITAL RECORDS NOTE CARDIAC ARREST AT HOME, 45 MINUTES CPR, CODE CALLED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT 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
    693928 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3361-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death (B)(4), (B)(4), (B)(4)