BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2051750 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04959
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    August 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO FURTHER DETAILS HAVE BEEN PROVIDED. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. ENGINEERING CALCULATIONS CONFIRMED THE LONGEVITY OF THIS DEVICE WAS NOT AS EXPECTED. THE DEVICE CASE WAS OPENED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN INTEGRATED CIRCUIT (IC). DETAILED ANALYSIS CONFIRMED THAT THE IC ISSUE CREATED THE HIGH CURRENT CONDITION CONTRIBUTING TO THE OBSERVED CLINICAL OBSERVATION OF EARLY BATTERY DEPLETION.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND IS INTENDED TO BE RETURNED FOR A POST MARKET ASSESSMENT. THE ASSOCIATED ATRIAL LEAD WAS TESTED WITH THE NEW DEVICE AND APPROPRIATE FUNCTION CONFIRMED. THE LEAD REMAINED IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE IMPLANTED LESS THAN 12 MONTHS, WAS EXHIBITING LESS THAN ONE YEAR OF REMAINING SERVICE LIFE. AN INQUIRY WAS SENT FOR TECHNICAL REVIEW, AT WHICH TIME IT WAS COMMUNICATED A MEMORY FILE WOULD BE REQUIRED FOR ASSESSING LONGEVITY PERFORMANCE. ADDITIONALLY, A DEVICE ALERT NOTIFICATION TO CHECK THE ASSOCIATED ATRIAL LEAD HAD BEEN OBSERVED. NO INFORMATION PROVIDED ON THE SPECIFICS OF THE FAULT CODE OR THE ATRIAL LEAD MODEL SERIAL NUMBER. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND TO DATE THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    DEVICE HISTORY INFORMATION WAS SENT TO BOSTON SCIENTIFIC FOR ASSESSMENT OF THE REPORTED CLINICAL OBSERVATIONS. THE ENGINEERING ASSESSMENT CONFIRMED THE DEVICE WAS CONSUMING A LARGER AMOUNT OF ENERGY THAN EXPECTED AND THE PRODUCT WOULD NEED TO BE EXPLANTED AND RETURNED FOR A DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention