BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2913679 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00483
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    September 12, 2011
    Report Date
    December 20, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. 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 THE IMPLANT PROCEDURE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HIGH OUT OF RANGE SHOCK IMPEDANCES WERE DISPLAYED. THE PHYSICIAN TURNED OFF ALL ELECTRICAL EQUIPMENT AND MEASURED AGAIN WITH SHOCK IMPEDANCES MEASURING ABOVE 125 OHMS. THE DEVICE WAS REMOVED FROM THE POCKET AND THE LEAD WERE CHECKED AND EVERYTHING WAS CONNECTED CORRECTLY. THE SHOCK COILS WERE REMOVED FROM THE HEADER AND CLEANED AND IMPEDANCE MEASUREMENTS WERE STILL AT 125 OHMS. THE DEVICE WAS TESTED WITH A 21 JOULE SHOCK AND AFTER DFT TESTING THE IMPEDANCE MEASUREMENT WAS 55 OHMS. THIS IMPLANT WAS COMPLETED SUCCESSFULLY WITH NORMAL IMPEDANCE MEASUREMENTS OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20593 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P143

    Patients

    Seq Age Sex Outcome Treatment
    1