BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3211604 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09642
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN AV NODE ABLATION THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO VVI 40 PPM. THERE WERE TWO DROPPED BEATS RECORDED ON AN ELECTROCARDIOGRAM AS THE PATIENT WAS BECOMING PACER DEPENDENT, AND THE PAUSE WAS ABOUT TWO SECONDS. THE FIELD REPRESENTATIVE CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND THE REASON FOR THIS OBSERVATION WAS DISCUSSED; THE IMPULSE FROM THE ABLATION PROCEDURE WAS OVERSENSED BY THE DEVICE AND IMPACTED PACING THERAPY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER OBSERVATIONS BEING NOTED AND THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310331 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4542| 0296| N140