BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050105 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00571
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    July 26, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT PRESENT. THE MEDTRONIC FIELD REP REMOVED EXCESS EXAMS FROM THE SYSTEM'S HARD DRIVE. THE SYSTEM WAS USED SUCCESSFULLY IN A CASE W/O ANY ISSUES OF FREEZING OR SLOWNESS AFTER THE EXCESS EXAMS WERE REMOVED. CLEARING OUT HARD DRIVE SPACE RESOLVED THE ISSUE. IT IS RECOMMENDED TO THE USER TO PERIODICALLY REMOVE EXCESS EXAMS FOR THIS REASON.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THAT THE SURGEON AND STAFF EXPRESSED CONCERN ABOUT THEIR SYSTEM FREEZING AND BEING SLOW. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1