BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1944977 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20725
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    August 30, 2010
    Report Date
    October 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT REMAINS IN SERVICE, IT WILL NOT BE RETURNED FOR ANALYSIS AND BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO ADDITIONAL INFORMATION RELATED TO THIS EVENT AVAILABLE, OR TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), LOSS OF CAPTURE AND GREATER THAN 2000 OHMS IMPEDANCE MEASUREMENTS WERE OBSERVED. A BOSTON SCIENTIFIC TECHNICAL CONSULTANT DISCUSSED VARIOUS METHODS OF TROUBLESHOOTING THE ISSUE. THE CASE RESOLVED THROUGH REESTABLISHING SECURE CONNECTIONS OF THE LEADS WITH THE CRT-D. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P106

    Patients

    Seq Age Sex Outcome Treatment
    1