BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2081286 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00821
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 11, 2010
    Report Date
    May 6, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REP BROUGHT IN PORTABLE INAV SYS TO COMPETE CASE AS SITE WAS HAVING ISSUES WITH THE MONITOR ON THE TRIA SYS. SURGERY COMPETED WITH NO IMPACT ON PT OUTCOME.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED INTERMITTENT TRACKING ISSUES DURING A BIOPSY PROCEDURE. THE BIOPSY WAS TAKEN SUCCESSFULLY AND THERE WAS NO IMPACT ON THE OUTCOME OF THE PT AS A RESULT OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1