BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 637936 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06766
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    December 8, 2003
    Report Date
    December 8, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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'S FAMILY REPORTED THAT THE PATIENT DIED FROM PNEUMONIA AND A STAFF INFECTION OF THE SPINE. THE FAMILY ALSO REPORTED THAT THE PATIENT'S PHYSICIAN ALLEGED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1861 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death