BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2152447 · Received June 28, 2011

    Report

    Report Number
    1723170-2011-01167
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED THAT WHILE IN AN ENT PROCEDURE THE SURGEON HAD DIFFICULTY COMPLETING REGISTRATION, THEN WAS ABLE TO SUCCESSFULLY COMPLETE A POINTMERGE REGISTRATION AND TO TRACK SUCCESSFULLY. FURTHER INTO THE CASE, THE SURGEON ATTEMPTED TO TRACK THE INSTRUMENT AND IT TRACKED INTO SPACE ON THE 2D IMAGES. THE RN COULD NOT CONFIRM IF ANYTHING HAD MOVED. THE SURGEON OPTED TO COMPLETE THE PROCEDURE W/O THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR