BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2060032 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06395
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED LOSS OF CAPTURE. THE PATIENT IS PACER DEPENDENT AND WHEN LV ONLY THRESHOLD TESTS WERE PERFORMED, THE PATIENT WAS LIGHTHEADED. IT WAS NOTED THAT THE PATIENT WAS INVOLVED IN AN ACCIDENT WITH AIR BAGS DEPLOYMENT AND HAS NOT FELT WELL SINCE. THE LEAD IMPEDANCE MEASUREMENTS AND SENSING HAVE BEEN STABLE. SEVERAL MONTHS AFTER THE ACCIDENT, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. ADDITIONAL INFORMATION INDICATED THAT A REVISION PROCEDURE WAS NOT PERFORMED AS THERE WAS NO LEAD FRACTURE. THE DEVICE WAS REPROGRAMMED TO RV ONLY. IT WAS NOTED THAT THE PATIENT WAS SEEN IN THE CLINIC AND INDICATED THEY FEEL GREAT.

    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 61 YR 1388T| 0158| H179| N118| 4513| MISMATCH