BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2173633 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10651
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 19, 2011
    Report Date
    January 13, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WILL CONTINUE WORKING WITH THE MEDICAL STAFF. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS EVENT HAS BEEN CORRECTED DUE TO FURTHER INVESTIGATION.

    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. 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 ALLEGATION OF HIGH SHOCK IMPEDANCES COULD NOT BE CONFIRMED IN ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HIGH SHOCK IMPEDANCE WAS DETECTED. A LOCAL AREA SALES REPRESENTATIVE CHECKED THE PATIENT'S DEVICE. ISOMETRICS AND POCKET MANIPULATION WERE PERFORMED WHILE TESTING THE SHOCK LEAD IMPEDANCES AND ALL MEASUREMENTS WERE BETWEEN 80-90 OHMS. THE DAILY MEASUREMENTS ALSO SHOWED THE SHOCK IMPEDANCES WERE STABLE AT 80-90 OHMS.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED APPROXIMATELY FIVE YEARS LATER FOR UNRELATED REASONS. THAT ISSUE WAS REPORTED IN MFR #2124215-2015-16942.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4135| E110