BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1952294 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24117
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. ANALYSIS OF THE ASSOCIATED LEADS CONCLUDED THE EVENT OCCURRED AS A RESULT OF IMPROPER INSERTION OF THE LEAD INTO THE DEVICE HEADER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING AN IMPLANT PROCEDURE, NOISE WAS SENSED. LEFT VENTRICULAR (LV) AND RIGHT VENTRICULAR (RV) PACING IMPEDANCES WERE GREATER THAN 2,000 OHMS. THE DEVICE WHICH WAS PREVIOUSLY CONNECTED WAS REPLACED. WITH THIS REPLACEMENT DEVICE, NOISE AND OUT OF RANGE IMPEDANCES WERE STILL OBSERVED. THE DEVICE REMAINED IMPLANTED AND FURTHER TESTING WAS SCHEDULED. THE LV CONFIGURATION WAS LATER CHANGED, RESOLVING THE OBSERVED OUT OF RANGE LV IMPEDANCE AND NOISE. A REVISION PROCEDURE WAS PERFORMED. AS THE RV LEAD WAS DISCONNECTED, BLOOD IN THE HEADER WAS NOTED. DESPITE TROUBLESHOOTING, NO PACING OR SENSING WAS OBSERVED, AND THE DEVICE WAS REPLACED. 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 P108

    Patients

    Seq Age Sex Outcome Treatment
    1