BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1860563 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15233
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. A BOSTON SCIENTIFIC CRM TECHNICAL CONSULTANT REVIEWED THE SAVE TO DISK AND DISCUSSED THAT VOO PACING WAS NOT OBSERVED DURING THE ATRIAL ABLATION PROCEDURE AND THE PHYSICIAN HAD TO PAUSE DURING THE PROCEDURE TO ALLOW FOR PACING TO CONTINUE. THE DEVICE WAS TAKEN OUT OF STORAGE MODE AND TURNED TO TACHY OFF FOLLOWED BY MONITOR + THERAPY. THE PROGRAMMING OF MONITOR + THERAPY OCCURRED AFTER THE ATR EPISODES WERE STORED IN THE DEVICE. THE ATR EPISODES SHOW WHAT APPEARS TO BE ELECTROCAUTERY OR ABLATION TYPE NOISE. THE BRADY MODE DURING THIS TIME WAS DDD IN ORDER TO ALLOW FOR ATR TO BE STORED AND ONE CAN SEE THAT THE VENTRICLE IS BEING PACED OR INHIBITED DEPENDING ON THE NOISE. VOO CANNOT BE PERMANENTLY PROGRAMMED ON IN THE COGNIS DEVICE AND WOULD ONLY BE AVAILABLE IF OFF ELECTROCAUTERY MODE WERE ENABLED. THERE IS NO INDICATION THAT THE BRADY PROGRAMMING WAS EVER CHANGED USING OFF ELECTROCAUTERY MODE. OFF ELECTROCAUTERY MODE MUST BE ENABLED FOR DOO OR VOO PACING TO BE IN EFFECT. THE POP-UP MESSAGE WILL REMAIN ON THE SCREEN UNTIL THE MODE IS CANCELLED. THE DEVICE APPEARS TO HAVE OPERATED NORMALLY PER THE PROGRAMMING AT THE TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE; AFTER THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR WAS IMPLANTED, AN ABLATION OF THE AV NODE WAS PERFORMED. DURING THE ABLATION, IT WAS NOTED THAT THE DEVICE WAS PROGRAMMED TO VOO CONFIGURATION AND WAS NOT PACING. PACING WAS INHIBITED AND THERE WERE NO SPONTANEOUS BEATS. ONCE THE ABLATION PROCEDURE WAS STOPPED, THE DEVICE BEGAN DELIVERING PACING THERAPY. THE DEVICE WAS SUCCESSFULLY IMPLANTED AND REMAINS IN SERVICE. A SAVE TO DISK WAS PERFORMED AND SENT TO A BOSTON SCIENTIFIC CRM TECHNICAL CONSULTANT FOR REVIEW. 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 P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other