BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2060819 · Received March 11, 2011

    Report

    Report Number
    1723170-2011-00630
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. MEDTRONIC EVALUATION SHOWED THAT THE DRIVER SQUEAKS AND GRINDS WHEN THE HANDLE IS ROTATED, BUT THE DRIVER IS FUNCTIONAL, ACCEPTING BOTH HANDLE AND INSTRUMENTS WITHOUT ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN AWL/PROBE/TAP (APT) DRIVER THAT WAS LOCKING UP DURING A DEMO USING THE STEALTHSTATION TREON. NO PATIENT 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