BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1764847 · Received July 21, 2010

    Report

    Report Number
    2124215-2010-11847
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REPORTED SHORTNESS OF BREATH AND TIREDNESS. THE PATIENT ALSO REPORTED A PULSE IN THE 40'S AND A LOW BLOOD PRESSURE. THE PATIENT WAS CONCERNED THAT THE DEVICE WAS NOT PACING AT THE LOWER RATE LIMIT (LRL). IN A REVIEW OF LATITUDE (WHICH IS A REMOTE MONITORING SYSTEM) INFORMATION, THE LRL HAD BEEN PROGRAMMED TO 70 PPM SIX MONTHS PRIOR. TO DATE, THERE HAVE BEEN 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 N118

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4470| N118| H179| 4513| 1861| 0158