BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2052106 · Received March 1, 2011

    Report

    Report Number
    1723170-2011-00170
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. INVESTIGATION OF THIS DEVICE FOUND THAT THE PSU DISPLAYED HIGH GEOMETRY FOR BOTH ACTIVE AND PASSIVE INSTRUMENTS. THERE WERE TOO FEW MARKERS VISIBLE TO RUN THE AAK TEST. THE PSU WAS OUT OF CALIBRATION. A REPLACEMENT PART WAS SENT TO THE SITE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THE STEALTHSTATION POSITIONING SENSOR UNIT (PSU OR CAMERA) WAS BROKEN. NO PT 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