BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3053561 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05125
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE HAD TELEMETRY AND OUTPUT UPON RETURN. 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 THE DEVICE DISPLAYING THE FAULT CODE.

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION WILL BE COMMUNICATED TO THE PHYSICIAN SO THAT THE NEXT COURSE OF ACTION CAN BE TAKEN. AT THIS TIME, THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    A BOSTON SCIENTIFIC ENGINEER REVIEWED THE DATA AND DISCUSSED THAT AN EVENT OCCURRED AN ABNORMALLY HIGH CURRENT EVENT OCCURRED ON ONE DAY IN (B)(6) 2013 WHICH RESULTED IN A DEVICE RESET AND THE OBSERVED FAULT CONDITION. SINCE THIS OCCURRENCE, THE POWER CONSUMPTION HAS REMAINED ELEVATED, WHICH IS RESULTING IN A HIGH CURRENT DRAIN CONDITION. AS A RESULT, DEVICE REPLACEMENT SHOULD BE STRONGLY CONSIDERED TO ENSURE THAT THE PATIENT IS ADEQUATELY PROTECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THE FAULT CODE 1003 AND THE WARNING MESSAGE THAT THE VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A MEMORY DOWNLOAD WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER EVALUATION. A TS CONSULTANT DISCUSSED THAT THE FAULT INDICATES THAT THERE IS AN ADDITIONAL CURRENT DRAIN ON THE DEVICE'S BATTERY AND THE DATA ANALYSIS WILL HELP DETERMINE HOW MUCH LONGER THE DEVICE HAS ENOUGH ENERGY TO SUSTAIN NORMAL FUNCTION. IT WAS ALSO DISCUSSED THAT DEVICE REPLACEMENT SHOULD BE CONSIDERED AS SOON AS POSSIBLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156433 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R