BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2081196 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00809
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    January 14, 2010
    Report Date
    January 14, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED, THE PSU HAD SEVERAL BROKEN STANDOFFS INSIDE. DURING A FUNCTIONAL TEST, THE POSITION SENSOR UNIT (PSU) RETURNED HIGH GEOMETRY FOR AN ACTIVE FRAME. THE VOLUME WAS ONLY SLIGHTLY REDUCED AT THE BACK EDGE FOR THE PASSIVE PROBE. THERE WERE TOO FEW MARKERS VISIBLE TO RUN THE AAK TEST. THE PSU IS OUT OF CALIBRATION.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED, THE CAMERA ON THE SITE'S TRIA SYSTEM WAS NOT TRACKING THE INSTRUMENTATION. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    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