BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3053609 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05257
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REVIEW OF THE DATA WAS PERFORMED. ALL MEASUREMENTS WERE WITHIN ACCEPTABLE RANGE AND NO NOISE WAS NOTED. A DECISION WAS MADE TO FURTHER MONITOR THIS SYSTEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN AND IS BEING FURTHER MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155869 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P106

    Patients

    Seq Age Sex Outcome Treatment
    1