BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1863671 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15743
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    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 CRM RECEIVED INFORMATION THAT, DURING THE IMPLANT PROCEDURE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PHYSICIAN HAD TROUBLE INSERTING THE RIGHT ATRIAL (RA) LEAD INTO THE RA PORT. THERE WAS ALSO NOISE ON THE ATRIAL CHANNEL AND HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THE RA LEAD WAS REINSERTED SEVERAL TIMES AND THE PHYSICIAN WAS ABLE TO INSERT THE LEAD WITHOUT SEEING NOISE AND WITH GOOD IMPEDANCE MEASUREMENTS. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WHICH CONVERTED THE PATIENT FROM ATRIAL FIBRILLATION INTO NORMAL SINUS RHYTHM. SHORTLY AFTER, THE RA PACING IMPEDANCE MEASUREMENTS WERE OUT OF RANGE. TECHNICAL SERVICES (TS) DISCUSSED THAT WITH NOISE ON THE RA LEAD AND OUT OF RANGE IMPEDANCE MEASUREMENTS, THERE COULD BE AN INTERMITTENT CONNECTION PROBLEM. IT WAS NOTED THAT THE PHYSICIAN WAS WAITING TO SEE IF THE PATIENT GOES BACK INTO ATRIAL FIBRILLATION OR REMAINS IN NORMAL SINUS RHYTHM TO DETERMINE WHETHER OR NOT TO SURGICAL INTERVENTION IS NECESSARY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT A CHEST X-RAY WAS PERFORMED; HOWEVER, THE RESULTS ARE UNKNOWN AT THIS TIME. THE PLAN AT THIS TIME IS TO MONITOR THE PATIENT.

    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