BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1945738 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20283
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    September 29, 2010
    Report Date
    February 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS LATER EXPLANTED DUE TO A PATIENT CONDITION. THE LEAD WAS SURGICALLY ABANDONED. THE DEVICE WAS RETURNED FOR ANALYSIS AND DETAILED ANALYSIS IS PENDING.

    Additional Manufacturer Narrative · 1

    A TECHNICAL SERVICES CONSULTANT RECOMMENDED CHANGING THE SENSITIVITY TO RESOLVE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. AS OF TODAY THE DEVICE REMAINS IN SERVICE.

    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 WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE OVERSENSED NOISE ON THE RIGHT VENTRICULAR CHANNEL RESULTING IN PACING INHIBITION AND ASYSTOLE FOR MORE THAN TWO SECONDS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention H177| 0158| N119| 4087