BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1945701 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20863
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    May 20, 2010
    Report Date
    December 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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

    THE DEVICE WAS LATER RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED FLUCTUATING LEFT VENTRICULAR (LV) LEAD IMPEDANCES SINCE IMPLANT. THERE WERE NO OUT OF RANGE MEASUREMENTS. TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE REASONS FOR THE VARIABLE MEASUREMENTS, AND RECOMMENDED A COMPLETE FOLLOW-UP ON THE LEAD. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT AN LV LEAD REVISION WAS PERFORMED. WHEN THE POCKET WAS OPENED, ALL THREE OF THE PATIENT'S LEADS WERE KNOTTED TOGETHER. THE PHYSICIAN SUSPECTED THAT THE PATIENT IS A TWIDDLER, BUT NOTED THAT THE DEVICE WAS LOOSELY MOVING IN THE POCKET. THE LEAD WAS EXPLANTED AND THE PHYSICIAN WISHED TO IMPLANT THE DEVICE SUB-PECTORALLY DUE TO THE PATIENT POSSIBLY BEING A TWIDDLER; HOWEVER, THIS DEVICE COULD NOT BE IMPLANTED SUB-PECTORALLY DUE TO THE SUBPECTORAL IMPLANT 2009 ((B)(6) 2009) ADVISORY. THE DEVICE WAS THEREFORE EXPLANTED AND REPLACED AS WELL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)