BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1852655 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14522
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) RATE/SENSE CHANNEL WHICH WAS OVERSENSED AND RESULTED IN NON-SUSTAINED EPISODES. PACING WAS INHIBITED FOR JUST OVER TWO SECONDS. ALL MEASUREMENTS WERE WITHIN RAGE. TECHNICAL SERVICES (TS) DISCUSSED BRINGING THE PATIENT INTO THE OFFICE FOR FURTHER EVALUATION AND TRYING TO REPRODUCE THE NOISE. TS DISCUSSED THAT THE NOISE MORPHOLOGY RESEMBLED THAT OF A LEAD FRACTURE RATHER THAN ELECTROMAGNETIC INTERFERENCE OR MUSCLE STIMULATION. TS ALSO DISCUSSED THE POSSIBILITY OF SEAL PLUG DAMAGE BUT THIS WAS LESS LIKELY. THE AUTOMATIC GAIN CONTROL WAS ADJUSTED PER THE PHYSICIAN'S RECOMMENDATION AND THE PATIENT WILL BE MONITORED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    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 71 YR N119| 4086| 4555| 0184