BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3043099 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01816
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECEIVED INAPPROPRIATE SHOCKS WHICH COULD NOT BE PULL UP ON IN THE LOGBOOK. THE EPISODE WAS INITIALLY DETECTED IN THE VT-1 MONITOR ONLY ZONE. THE HISTOGRAMS INDICATED THAT THE COMPETITOR'S LEFT VENTRICULAR (LV) LEAD PACING WAS AT 27 PERCENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE RATE ESCALATED INTO THE VT ZONE AND THERAPY WAS GIVEN. TS ALSO DISCUSSED THAT THE LV COULD BE PICKING UP NOISE OR LEFT SIDED VENTRICULAR OR ATRIAL ACTIVITY. TS SUGGESTED A CHEST X-RAY TO VERIFY LEAD PLACEMENT AND TURNING OFF LV SENSING OR CHANGING THE LV CONFIGURATION TO GET BETTER SENSING AND PACING THRESHOLD MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147484 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 1852| E102| MISMATCH| N119| 4136| 0185