BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 710631 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-14064
    Event Type
    Injury
    Date Received
    May 9, 2006
    Date of Event
    March 6, 2006
    Report Date
    March 6, 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED TONES AND WAS FOUND TO BE AT END OF LIFE (EOL), WHICH WAS TRIPPED BY A 45 SECOND CHARGE TIME (CT). THE MONITORING VOLTAGE (MV) WAS 3.16 V AT BEGINNING OF LIFE (BOL). THE DEVICE WAS RECHECKED THE NEXT DAY AND SHOWED 45 SECOND CT. OTHER MANUAL CAPACITOR REFORMATIONS (MCF) REVEALED CT OF 30 AND 45 SECONDS AND EOL MESSAGE. BATTERY IS STILL AT 3.16V. THE DEVICE DISPLAYED A FC01 AND 45 SECOND MCF. THREE CONSECUTIVE MCF ALL SHOWED CT OF LESS THAN 6 SECS. A MEMORY DUMP AND SAVE TO DISK WILL BE SENT IN FOR EVALUATION. ,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR LWS CARDIAC PACEMAKERS, INC H175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention