BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1946639 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-21571
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    February 12, 2010
    Report Date
    October 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE EXHIBITED A SINGLE EVENT UPSET (SEU). SEU IS A CHANGE OF STATE CAUSED BY IONS OR ELECTRO-MAGNETIC RADIATION STRIKING A NODE IN A MICRO-ELECTRONIC DEVICE. STATE CHANGE IS A RESULT OF A FREE CHARGE CREATED BY IONIZATION IN OR CLOSE TO A NODE OF A LOGIC ELEMENT -- MEMORY LOCATIONS IN THIS CASE. THUS, WHEN INTERROGATED WITH A PROGRAMMER, THE DEVICE RETURNED AN ERROR ON THE PROGRAMMER. 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. HISTORICAL DATA INDICATES SINGLE EVENT UPSETS SUCH AS THE ONE THIS CRT-D RECORDED MAY BE THE RESULT OF COSMIC RADIATION. THIS ANALYSIS CONCLUDES THE INVESTIGATION. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DETERMINED TO BE IN SAFETY MODE PRIOR TO ATTEMPT TO IMPLANT. THE LOCAL AREA SALES REPRESENTATIVE HAD PERFORMED THE INITIAL INTERROGATION. THE DEVICE WAS NEVER IMPLANTED AND WAS TO BE RETURNED FOR ANALYSIS.

    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