BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4884360 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07177
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 20, 2015
    Report Date
    July 1, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE CLINICAL OBSERVATIONS WERE UNABLE TO BE CONFIRMED OR DUPLICATED DURING LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE OVERSENSED MYOCARDIAL NOISE ON THE RIGHT VENTRICULAR (RV) LEAD RESULTING IN NUMEROUS INAPPROPRIATE SHOCKS. CURRENT IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS AND LOSS OF CAPTURE (LOC) WAS OBSERVED. A LEAD FRACTURE WAS SUSPECTED BUT WAS NOT VISUALLY CONFIRMED. SURGICAL INTERVENTION WAS PERFORMED AND THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND REPLACED WHILE THE SHOCKING/HIGH VOLTAGE PORTION OF THE LEAD REMAINS IN SERVICE. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424642 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 4087| E110