BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2173326 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10629
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    August 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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 ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. 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 WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    OUR RECORDS SHOW THE DEVICE AND RV LEAD WERE TAKEN OUT OF SERVICE. SHOULD THE PRODUCTS GET RETURNED, THEY WILL BE ANALYZED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT RECEIVED TWO DEFIBRILLATION SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FROM NOISE ON THE RIGHT VENTRICULAR (RV) P/S CHANNEL. THE PATIENT WAS BROUGHT IN FOR TESTING AND WHEN TACHYCARDIA THERAPY WAS TURNED OFF, IMPEDANCE MEASUREMENTS RANGED FROM 1400 OHMS TO GREATER THAN 2000 OHMS. ISOMETRICS WERE ALSO ABLE TO REPRODUCE NOISE. TECHNICAL SERVICES DISCUSSED BASED ON NOISE ON ONLY RV PACE/SENSE CHANNEL, OUT OF RANGE IMPEDANCES AND AGE OF LEAD, THIS COULD EITHER BE A LATENT CONNECTION RELATED ISSUE OR A LEAD PROBLEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 0180| E102