BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2911356 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15997
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 23, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. IT WAS THOUGHT THIS ISSUE WAS DUE TO A LEAD ISSUE, HOWEVER IT COULD NOT BE DETERMINED WHETHER THERE WAS POSSIBLE DEVICE INVOLVEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED OVERSENSING RESULTING IN GREATER THAN TWO SECONDS ASYSTOLE. THIS OCCURRED WHILE THE PATIENT WITH THIS DEVICE AND RIGHT VENTRICULAR LEAD WAS WORKING WITH SOME ELECTRICAL WOODWORKING MACHINES. ALL OTHER EAD MEASUREMENTS WERE NORMAL. THE DEVICE SENSITIVITY WAS REPROGRAMMED. A DATA DOWNLOAD WAS PROVIDED TO AN INTERNAL TECHNICAL SERVICE CONSULTANT FOR THEIR REVIEW. IT WAS DETERMINED THE NOISE WAS CONSISTENT WITH MYOPOTENTIALS. IN ADDITION, DECREASED IMPEDANCE MEASUREMENTS WERE NOTED. FURTHER LEAD INTEGRITY MANEUVERS AND LEAD MONITORING WERE RECOMMENDED. AS OF THIS DATE, THIS DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16532 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P143

    Patients

    Seq Age Sex Outcome Treatment
    1