BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 1852665 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14342
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    September 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED APPROXIMATELY ONE YEAR LATER INDICATED THE PATIENT HAD ANOTHER EPISODE OF NOISE WITH PACING INHIBITION REPORTED. THE PAUSE IN PACING WAS JUST UNDER TWO SECONDS. THERE WAS ONLY ONE EPISODE AND THE PATIENT WAS ASYMPTOMATIC. IT WAS REPORTED THE PATIENT USES A LOT OF FARM EQUIPMENT SO THE PATIENT KEEPS A LOG RECORDING THOSE EVENTS. THE PATIENT PLANNED TO REVIEW THE LOG TO DETERMINE IF IT CORRELATED WITH THE TIME OF THE EPISODE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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. 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.

    Additional Manufacturer Narrative · 1

    THE SENSITIVITY OF THE DEVICE WAS CHANGED TO RESOLVE THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE OVERSENSED NOISE RESULTING IN PACING INHIBITION. THE PATIENT WAS PACEMAKER DEPENDANT AND WAS SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H227

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 4473| 0185| 4592| H227| 4543| 0175