BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1871663 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18087
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    October 20, 2011
    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 SHOW 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 VIA A LATITUDE RED ALERT, THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND LOSS OF LV CAPTURE. THE FIELD REPRESENTATIVE CHANGED THE PACING CONFIGURATION TO TIP TO RIGHT VENTRICULAR (RV) COIL WHICH RESOLVED THE ISSUE. THE LEAD REMAINS IMPLANTED AT THIS TIME WITH NO FURTHER COMPLICATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT LOST CRT THERAPY AND NOTICED A LACK OF ENERGY. THE CAUSE OF THE OUT OF RANGE IMPEDANCES COULD NOT BE DETERMINED AS THE ONLY DATA WAS THE OUT OF RANGE IMPEDANCE MEASUREMENTS AND LOSS OF LV CAPTURE IN THE TIP TO RING CONFIGURATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED A REVISION PROCEDURE WAS PERFORMED DUE TO A LEAD FRACTURE. THE LEAD WAS EXPLANTED. THIS DEVICE REMAINS IMPLANTED AT THIS TIME WITH NO FURTHER ISSUES REPORTED.

    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 77 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)