BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3053132 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05500
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS PATIENT'S DEVICE REMAINS IN-SERVICE AND NO INVASIVE INTERVENTION WAS UNDERTAKEN. 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

    THE INVESTIGATION OF THIS EVENT IS ON-GOING AS A REQUEST HAS BEEN MADE TO THE LOCAL REPRESENTATIVE TO OBTAIN ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    DESPITE MULTIPLE ATTEMPTS, ADDITIONAL INFORMATION WAS NOT AVAILABLE FROM THE FIELD. THE AVAILABLE INFORMATION SUGGESTS THAT THIS LEAD 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S MONITORING SYSTEM DETECTED A RED ALERT (HIGH SHOCK IMPEDANCE). THE CLINIC HAD ALREADY REVIEWED THE DATA FROM THE PATIENT'S MONITORING SYSTEM AND A CALL WAS MADE TO THE LOCAL REPRESENTATIVE TO DISCUSS THE ISSUE.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156394 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4549| N119| 4470| 0181