BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2081516 · Received April 19, 2011

    Report

    Report Number
    1723170-2011-00878
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT THE ENT APPLICATION EXITED W/O WARNING. NO PATIENT HARM REPORTED.

    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 NONE