BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1945059 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20527
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 30, 2009
    Report Date
    October 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BSC TS REPRESENTATIVE DISCUSSED PROGRAMMING THE DURATION OUT AND HAVING THE NEXT PATIENT FOLLOW UP WITHIN ON MONTH TO RE-EVALUATE THE NOISE. THE CAUSE OF THE NOISE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED WITH NOISE SIGNALS EVERY 200 MILLISECONDS (MS) THAT RESULTED IN TACHYCARDIA OVERSENSING. THESE EPISODES OCCURRED TWICE IN APPROXIMATELY THREE MONTHS AFTER IMPLANTATION. IN ADDITION, THERE WAS NOISE OBSERVED ON THE SHOCK ELECTROCARDIOGRAM THAT OCCURRED PRIOR TO THE NOISE CAUSING THE OVERSENSING. THE NOISE COULD NOT BE REPRODUCED THROUGH ISOMETRIC EXERCISES OR POCKET MANIPULATION. THE ORIGINAL PACE/SENSE LEAD IS BEING USED FOR PACING AND A DEFIBRILLATION LEAD WAS IMPLANTED FOR SHOCKING PURPOSES ONLY. WHEN THE CRT-D WAS IMPLANTED, THE PACING IMPEDANCES HAD INCREASED BUT THEN DECREASED TO 400 OHMS AND HAD REMAINED STABLE. THE PATIENT IS NOT PACEMAKER DEPENDANT BUT THERE WAS A SLIGHT PAUSE IN PACING FOR LESS THAN ONE SECOND. BSC TECHNICAL SERVICES WAS CONTACTED FOR TECHNICAL ADVICE. 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 N107

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)