BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1042998 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33639
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 19, 2008
    Report Date
    April 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    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 PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REPORTED RECEIVING A SHOCK WHILE SLEEPING, WHICH WOKE THEM UP. TECHNICAL SERVICES ADVISED THE PATIENT TO FOLLOW UP WITH THEIR PHYSICIAN. THE PATIENT'S INFORMATION WAS REVIEWED VIA LATITUDE AND A VENTRICULAR FIBRILLATION (VF) EPISODE RESULTING IN A SHOCK WAS NOTED TO HAVE BEEN RECORDED ON THE DAY THE PATIENT REPORTED RECEIVING A SHOCK. REVIEW OF THE STORED ELECTROGRAM REVEALED THIS CRT-D RECORDED NOISE EXHIBITED BY THIS IMPLANTABLE RIGHT VENTRICULAR LEAD WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION AND AN INAPPROPRIATE SHOCK. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other THE DEVICE (B)(4) WAS IMPLANTED (B)(4) 2007| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS IMPLANTED (B)(4) 2007| THE DEVICE 4517/429334 WAS IMPLANTED 05-SEP-2007| THE DEVICE 6482 027870 WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE 0184/130301 WAS IMPLANTED 05-SEP-2007| THE DEVICE (B)(4) WAS IMPLANTED (B)(4) 2007| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE 4086/239982 WAS IMPLANTED 05-SEP-2007