BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRIZM DR

    MDR report key: 637485 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06378
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    October 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PASSED AWAY. THE PATIENT'S DAUGHTER WROTE IN TO GUIDANT WITH A MULTITUDE OF QUESTIONS REGARDING DEFIBRILLATOR FUNCTIONING DURING A DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1851 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death