BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT

    MDR report key: 710795 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13792
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    February 16, 2006
    Report Date
    February 16, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A CHARGE TIME OF 12 SECONDS 6 MONTHS AGO. IN MOL-1 WITH 2.64 V. CURRENTLY, THE CHARGE TIME IS 21.8 SEC. A FEW MANUAL CAPACITOR REFORMATIONS INCREASED THE CHARGE TIME TO 25 AND THE DEVICE DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE ATRIAL GENERATOR LWS CARDIAC PACEMAKERS, INC A135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other