BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 1253987 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40833
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 23, 2008
    Report Date
    July 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSITIVITY WAS REPROGRAMMED, AND THIS REPORTEDLY RESOLVED THE OVERSENSING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE HAS NOW BEEN EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE ON THIS RIGHT-VENTRICULAR PACE/SENSE LEAD (RV). THE NOISE WAS OBSERVED ON THE RV LEAD ONLY. THE LEAD PACING IMPEDANCE WAS NORMAL AROUND 500 OHMS. THE NOISE WAS REPRODUCIBLE WITH DEEP BREATHING. IN FOLLOW UP, PACING INHIBITION WAS REPORTED DUE TO THE OVERSENSED NOISE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R THE DEVICE 4543/(B)(4) WAS IMPLANTED (B)(6) 2008| THE DEVICE 4087/(B)(4) WAS IMPLANTED (B)(6) 2008| THE DEVICE 4087/282310 WAS IMPLANTED 31-JUL-2008| THE DEVICE 0185/116143 WAS IMPLANTED 24-FEB-2005| THE DEVICE 0185/(B)(4) WAS IMPLANTED (B)(6) 2005| THE DEVICE 6482 038215 WAS USED DURING THE EVENT.| THE DEVICE 4543/134698 WAS IMPLANTED 31-JUL-2008| THE DEVICE 6482/(B)(4) WAS USED DURING THE EVENT.