BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1944900 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19389
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    February 26, 2010
    Report Date
    October 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LATITUDE DATA SHOWED THAT THE ATRIAL PACING IMPEDANCE MEASUREMENTS WERE OFTEN >2000 OHMS, WITH INTERMITTENT NORMAL MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND COMPETITIVE LEAD REMAIN IN SERVICE. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND COMPETITIVE ATRIAL PACING LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCE MEASUREMENTS, FROM 800 OHMS PREVIOUSLY TO 1600 OHMS CURRENTLY. P-WAVES WERE 0.9MV WHEN THE PATIENT MOVED HER ARM. IT WAS NOTED THAT THE PATIENT HAD A CYST NEAR THE DEVICE CITE AND THE PHYSICIAN DID NOT PLAN TO MAKE ANY CHANGES UNTIL THE CYST HEALED. IT WAS LATER REPORTED THAT THE ATRIAL LEAD MEASUREMENTS HAD IMPROVED AND WERE STABLE, SO THE PHYSICIAN PLANNED TO CONTINUE MONITORING.

    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 73 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)