BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 2913293 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00409
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    October 19, 2012
    Report Date
    December 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION 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 THIS JUST POST IMPLANT OF THIS DEVICE, THE DEVICE RECEIVED AN OUT-OF-RANGE (OOR) SHOCKING LEAD IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS IN THE TRIAD CONFIGURATION, AND 86 OHMS IN THE COIL TO DEVICE CONFIGURATION. SO THE PHYSICIAN HOOKED UP THE LEAD TO THE CHRONIC DEVICE AND THE IMPEDANCE WAS NORMAL. THE PHYSICIAN THEN HOOKED UP THIS DEVICE ONCE AGAIN AND THERE WAS OUT OF RANGE IMPEDANCES. THE PHYSICIAN THEN ASKED FOR A DIFFERENT DEVICE AND HOOKED THE LEAD UP TO THIS NOW 3RD DEVICE, THERE WAS OOR IMPEDANCES ONCE AGAIN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THAT THE SHOCK LEAD IMPEDANCES ARE MORE SENSITIVE TO ELECTROMAGNETIC INTERFERENCE (EMI) AND THAT MIGHT BE AN ISSUE WITH THE PROXIMAL COIL OF THE LEAD. TS ALSO DISCUSSED THAT THEY COULD JUST UNPLUG ANY EMI SOURCES IN THE ROOM AND THEN DO ANOTHER LEAD IMPEDANCE TEST. THIS DEVICE WAS ULTIMATELY NOT USED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20351 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E161

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 0185| T175| E141| E161