BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1951006 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23951
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 21, 2010
    Report Date
    November 22, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS DETECTED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REGARDING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. AN X-RAY WILL BE PERFORMED IN THE NEAR FUTURE TO CHECK LEAD CONNECTION. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT AN X-RAY WAS NOT PERFORMED. DURING A RECENT FOLLOW-UP THE IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE WITHIN A NORMAL RANGE, SO NO INTERVENTION WAS NECESSARY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1