BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2050141 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00598
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHIC UNKNOWN. PER RMA AN LCD DISPLAY WAS SENT TO SITE FOR REPLACEMENT. PART WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SITE REPORTED THE LCD SUDDENLY STOPPED DISPLAYING ANY VIDEO, AND THE SCREEN WENT TOTALLY BLANK. THE SURGEON HAD JUST FINISHED THE NAVIGATION AIDED KNEE PROCEDURE WITH THE TRIA SYSTEM. USE OF THE SYSTEM WAS NOT DISCONTINUED AS THE SURGEON HAD JUST FINISHED THE CASE. NO IMPACT ON PATIENT OUTCOME 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