BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2171372 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10428
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    May 1, 2024
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS ISSUE WAS REVIEWED BY THE PHYSICIAN. THE DEVICE WAS REPROGRAMMED AND THE LEFT VENTRICULAR LEAD FUNCTION WAS DISABLED. THE DEVICE REMAINS IN SERVICE AND ABLE TO PROVIDE THERAPY. A LEAD REVISION WAS NOT PERFORMED AS AN ECHO REVEALED IMPROVED HEART STATUS. NO ADVERSE PATIENT EFFECTS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 0181| P107| P107| 0181