BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1944983 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20855
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    September 10, 2009
    Report Date
    October 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED AN IMPEDANCE OF 1176 OHMS ON A SINGLE MANUAL MEASUREMENT, ALL OTHER MANUAL MEASUREMENTS HAVE BEEN NORMAL AND IN THE 500 OHM RANGE. THERE WERE 1100 ATRIAL TACHYCARDIA RESPONSE (ATR) EPISODES AND MULTIPLE EPISODES OF PREMATURE ATRIAL CONTRACTIONS (PAC'S). THERE HAS BEEN NO REPORT OF PATIENT SYMPTOMS. TECHNICAL SERVICES (TS) RECOMMENDED PERFORMING POCKET MANIPULATION AND ISOMETRICS TO TRY AND RECREATE NOISE AND ALSO TAKE IMPEDANCE READINGS TO SEE IF CAN RECREATE ANY OUT OF RANGE MEASUREMENTS. TS DISCUSSED THAT WITH MULTIPLE ATR'S AND PAC'S, THEY WOULD LIKE TO SEE IF THE PATIENT WAS HAVING MANY SHORT ATRIAL ARRYTHMIAS OR IF THERE WAS A POSSIBLE LEAD ISSUE OR CONNECTION ISSUE CAUSING THE NOISE. IT WAS NOTED THAT THE PATIENT WOULD CONTINUE TO BE MONITORED.

    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 79 YR 4136| 4525| 0185| N118