BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3210911 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07970
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, 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 ANOMALY IN AN OXIDE LAYER WITHIN AN INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTED IN REPORTED CLINICAL OBSERVATION(S).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, A VOLTAGE TOO LOW FOR REMAINING CAPACITY FAULT MESSAGE WAS OBSERVED UPON INTERROGATION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312108 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R E110| 4574| 0175