BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1853596 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14935
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 21, 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 Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT, THE DEVICE WAS EXPLANTED. UPON EXPLANT, THE FIELD REPORTED THAT THERE DID NOT APPEAR TO ANY VISUAL DEFECTS TO THE HEADER. IN ADDITION, THE NON-BOSTON SCIENTIFIC LEAD WAS ALSO TAKEN OUT-OF-SERVICE AS THE PHYSICIAN WAS NOT RULING OUT A LEAD ISSUE AS WELL. THE DEVICE WILL BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND DETAILED ANALYSIS IS PENDING.

    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 ABNORMALITIES OR IRREGULARITIES ON THE HEADER OR ON THE SURFACE OF THE DEVICE EXCEPT FOR MINOR SCRATCHES AND DENTS ON THE SURFACE OF THE DEVICE THAT COULD HAVE BEEN INDUCED WHILE EXPLANTING THE DEVICE. HOWEVER, RECORDED MEMORY OF THE DEVICE INDICATED THAT DEVICE HAD RECORDED OUT OF RANGE ATRIAL LEAD IMPEDANCE OVER TWO MONTHS AGO AND RELATIVELY HIGH ATRIAL LEAD IMPEDANCE A FEW WEEKS AFTER THAT. THE ELECTROGRAM RECORDED BY THE DEVICE ONE DAY BEFORE THE EXPLANT DATE, INDICATED THAT THE ATRIAL LEAD HAD CAPTURED NOISE SIGNALS. 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 WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. IN CONCLUSION, THE NOISE AND LOSS OF CAPTURE ISSUES MIGHT NOT BE RELATED WITH DEVICE'S FUNCTIONALITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND NON-BOSTON SCIENTIFIC DEFIBRILLATION LEAD HAD A SYNCOPAL EPISODE AT HOME. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM AND HAD ANOTHER SYNCOPAL EPISODE. ALL LEAD VALUES WERE REPORTED AS NORMAL. THERE WAS ONLY ONE PREVIOUS EPISODE OF NOISE ON THIS LEAD. HOWEVER, NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS OR POCKET MANIPULATION. A LOSS OF CAPTURE WAS ALSO REPORTED. THE DEVICE WAS IMPLANTED SUBPECTORAL AND THE PHYSICIAN HAD SUGGESTED A POSSIBLE HEADER ISSUE.

    Description of Event or Problem · 1

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    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 E110

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention E110| 0158| 6947| 5076| 7274