BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1873826 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17370
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 31, 2010
    Report Date
    January 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION SUGGESTS THAT AN INVASIVE PROCEDURE TOOK PLACE AND NOISE WAS NOTE REPRODUCED. THE COMPETITOR RV LEAD WAS RE-INSERTED INTO THE DEVICE HEADER. THE COMPETITOR LEAD DID NOT SHOW ANY VISIBLE DAMAGE. PULLING AND MANIPULATING THE LEAD DID NOT PRODUCE NOISE. THE DEVICE AND LEAD REMAIN IMPLANTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT 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 DEFIBRILLATION, 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 WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY THIS DEVICE WAS EXPLANTED AND RETURNED. UPON ANALYSIS THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP NOISE WAS SEEN ON THE RIGHT VENTRICULAR CHANNEL WHICH RESULTED IN ASYSTOLE FOR > 2 SECONDS. AN INVASIVE PROCEDURE OF THIS CARDIAC RE-SYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS BEEN SCHEDULED. THE RIGHT VENTRICULAR LEAD IS A COMPETITOR LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    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 P107

    Patients

    Seq Age Sex Outcome Treatment
    1