BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1853595 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14904
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    December 5, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    T WAS LATER REPORTED THAT THIS PATIENT IS DEVICE-DEPENDANT. THE PHYSICIAN HAD ELECTED TO CHANGE THE SENSITIVITY AND DO FURTHER DEFIBRILLATION THRESHOLD TESTING.

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGESTS THESE PRODUCTS REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ALSO NOTED, THESE STORED EPISODES WERE NOTED WHILE THE PATIENT WAS ON A TREADMILL. SOME NOISE WAS REPRODUCIBLE. SHOCK IMPEDANCE VALUES THAT WERE MEASURED DURING ISOMETRICS WERE STABLE AND WITHIN RANGE.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED EXTERNAL NOISE ON THIS DEFIBRILLATION AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL LEAD. THIS NOISE RESULTED IN PACING INHIBITION. HOWEVER, THE SHOCK MORPHOLOGY SHOWS WHAT COULD BE AN INTRINSIC QRS COMING THROUGH. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS LATER EXPLANTED AND RETURNED FOR REPORTED NORMAL BATTERY DEPLETION 7 YEARS LATER.

    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 71 YR T165| 5076| E110| 0158