BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3002308 · Received March 13, 2013

    Report

    Report Number
    1723170-2013-00178
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE, AT THE SITE, REMOVED SEVERAL LARGE EXAMS AND THE CORE FILES FROM THE FUSION NAVIGATION SYSTEM; RESULTING IN SOFTWARE FUNCTIONING NORMALLY. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THE FUSION ENT APPLICATION WAS SLOW AND UNRESPONSIVE AFTER IMPORTING 2 EXAMS WITH 500 AND 400 IMAGES EACH. IT TOOK SEVERAL MINUTES TO MOVE BETWEEN TASKS IN THE APPLICATION. WHEN FIRST IMPORTING THE EXAM THE APPLICATION EXITED. THE APPLICATION WAS RE-LAUNCHED, HOWEVER, SOFTWARE REMAINED SLOW BETWEEN TASKS. IT WAS REPORTED THERE WERE 174 EXAMS, 17% OF THE HARD DRIVE SPACE WAS USED AND THERE WERE 2 CORE FILES ON THE SYSTEM. THIS WAS IDENTIFIED OUTSIDE OF SURGERY, THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104672 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1