BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3090350 · Received May 2, 2013

    Report

    Report Number
    1723170-2013-00307
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE WAS UNABLE TO PROVIDE ANY PATIENT DEMOGRAPHIC INFORMATION. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. ALL OF THE INSTRUMENTS TRACKED ACCURATELY AND THE SYSTEM WAS FULLY FUNCTIONAL. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE REP REVIEWED THE TRACING PATTERN PERFORMED BY THE SURGEON AND FOUND THAT THE PATTERN DID NOT COVER THE SIDES OF THE NOSE, WHICH WAS NOT PROTOCOL. THE REP RETURNED TO THE SITE TO ASSIST WITH THE NEXT SURGERY AND THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON FELT 3-4 MM INACCURATE DURING AN ENT CASE. THE MEDTRONIC REP WAS NOT PRESENT DURING THE SURGERY. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH NO NEGATIVE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191160 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1