BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1952868 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24637
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) UNDERWENT A NON-DEVICE RELATED PROCEDURE IN WHICH THEIR DEVICE HAD BEEN PROGRAMMED OFF. THE LATITUDE REMOTE MONITORING SYSTEM HAD DECLARED A RED ALERT FOR A CHANGE IN VENTRICULAR THERAPY. IT WAS DETERMINED THAT THE THERAPY HAD NOT BEEN PROGRAMMED BACK ON. THE PATIENT WAS BROUGHT INTO THE OFFICE AND THERAPY WAS PROGRAMMED BACK ON. AS OF TODAY, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    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 83 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)