BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3040723 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00832
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 4, 2013
    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. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD, IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), EXHIBITED INTERMITTENT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS AND NOISE. THE NOISE WAS NOT SENSED BY THE DEVICE. IT WAS REPORTED THAT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED WITH PATIENT ISOMETRICS, HOWEVER, MEASUREMENTS WENT DOWN TO 1,100 OHMS AFTER PATIENT ISOMETRICS WERE COMPLETED. A LEAD ISSUE WAS SUSPECTED. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. THE LEAD WAS SURGICALLY CAPPED AND ABANDONED AND A NEW LEAD WAS IMPLANTED. ADDITIONALLY, THE DEVICE WAS ELECTIVELY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142931 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 7122| 4135| E110