BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2162506 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07236
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED ONE EPISODE WHICH APPEARS TO BE FINE VENTRICULAR FIBRILLATION (VF) OR AIR BUBBLES. QUICK CONVERT WAS DELIVERED AND SUCCESSFULLY CONVERTED THE PATIENT. THERE APPEARED TO BE FIVE SECONDS OF ASYSTOLE DURING THIS EPISODE. THIS OCCURRED A FEW HOURS AFTER THE IMPLANT PROCEDURE. TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE SOURCES OF THE NOISE, SUCH AS AIR BUBBLES, GIVEN THE TIME OF EVENT RELATIVE TO THE IMPLANT PROCEDURE. THE PHYSICIAN DECIDED TO PERFORM A REVISION PROCEDURE AND UTILIZED THE PACE/SENSE LEAD FROM THE PREVIOUS PACEMAKER. IT WAS NOTED THAT THERE WERE NO OTHER EVENTS AFTER THIS ONE, AND THE REAL-TIME DEVICE APPEARS TO BE OPERATING NORMALLY.

    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 80 YR Required Intervention 4457| 1298| 5076