BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2172926 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10361
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. 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) UNDERWENT AN RIGHT ATRIAL (RA) ABLATION PROCEDURE. DURING THE PROCEDURE, OFF ELECTROCAUTERY MODE WAS ENGAGED. THE DEVICE INHIBITED PACING FOR GREATER THAN 2 SECONDS. IT WAS NOTED THE PATIENT IS PACER DEPENDENT. AFTER A FEW BEATS, THE RATE RETURNED TO NORMAL. TECHNICAL SERVICES (TS) DISCUSSED IF THERE IS TOO MUCH CURRENT AT THE TIP OF THE LEAD, THE DEVICE MAY INHIBIT PACING TO PROTECT ITSELF FROM EXTERNAL SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 0184| N118| 1270| 4512| 4053| 4034| H179