BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2061546 · Received March 16, 2011

    Report

    Report Number
    1723170-2011-00668
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE NOT AVAILABLE AT TIME OF THIS REPORT. AN RMA WAS ISSUED FOR THE REPLACEMENT OF THE COMPUTER. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A SLOWNESS OR FREEZE, IN THE STEALTHSTATION TREON GUIDANCE SYSTEM. THE SITE REPORTED THAT THE SYSTEM REBOOTS AND DEADLOCKS IN THE APPLICATION. THERE WAS NO PT 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