BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2911194 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15691
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    August 16, 2011
    Report Date
    November 20, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS DEVICE, BOTH THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCES, INCREASED THRESHOLDS AND NOISE. A REVISION PROCEDURE WAS DONE TO ASSES IF THE LEADS WERE FULLY INSERTED INTO THE DEVICE HEADER. THE PROCEDURE CONFIRMED THAT THE LEADS WERE FULLY INSERTED. THE LEADS AND DEVICE REMAIN IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16925 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR T125| 0158| 4469| 4542| N119