BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1771444 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12541
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY ANALYZED. ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL; WITH A MEMORY DOWNLOAD UNABLE TO BE PERFORMED. THE DEVICE CASE WAS THEN OPENED AND A BATTERY MEASUREMENT WAS OBTAINED; 0.24 VOLTS NOTED. DETAILED ANALYSIS WAS THEN CONDUCTED ON THE INTERNAL COMPONENTS. IT WAS DETERMINED THAT THE INABILITY TO INTERROGATE THIS DEVICE WAS DUE TO AN INTERNAL SHORT WITHIN THE TRANSFORMER WHICH RESULTED IN DAMAGE THROUGHOUT THE HYBRID. ENGINEERS CONCLUDE THAT THIS LIKELY HAPPENED 90 DAYS POST IMPLANT DURING A SCHEDULED CAPACITOR REFORMATION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO AN INABILITY TO ESTABLISH TELEMETRY OR INTERROGATE. TROUBLESHOOTING WAS PERFORMED WITH NO SUCCESS. MAGNET APPLICATION DID NOT RESULT IN BEEPING TONES. THIS ICD IS INTENDED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention