BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1993918 · Received January 13, 2011

    Report

    Report Number
    1723170-2011-00041
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. TESTS HAVE BEEN CONDUCTED, THE RESULTS HAVE NOT BEEN REPORTED TO MANUFACTURER AT THIS TIME.

    Description of Event or Problem · 1

    PRODUCT USER FACILITY CALLED AND REPORTED THAT THE SCREEN ON THE FUSION NAVIGATION SYSTEM WOULD INTERMITTENTLY SHUT DOWN AND GO TO A BLACK SCREEN FOR LONG PERIODS OF TIME. THE EVENT DID NOT HAPPEN DURING SURGERY AND NO PT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1