BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2050184 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-02929
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. THE DEVICE WAS REPROGRAMMED TO TURN LEFT VENTRICULAR (LV) PACING OFF. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS REPOSITIONED, WHICH RESOLVED THE DIAPHRAGMATIC STIMULATION.

    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 80 YR N118| 4517| 0185| E110| 4087