BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM AVT

    MDR report key: 711318 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13009
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    November 18, 2005
    Report Date
    February 22, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) ON 11/15/2005. THE DEVICE WAS THUS EXPLANTED ON 11/18/05. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM AVT IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other