BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1863699 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16648
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS DEVICE WAS REPROGRAMMED AFTER THE PATIENT PRESENTED TO A HOSPITAL WITH AN EXTENDED SLOW VENTRICULAR TACHYCARDIA (VT) THAT WAS BELOW THE PROGRAMMED THERAPY ZONES. THE VT WAS SUCCESSFULLY PACE-TERMINATED WITH NO ADVERSE PATIENT EFFECTS, AND THE DEVICE SUBSEQUENTLY REPROGRAMMED.

    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 55 YR 0157| 4549| N119| 5068