BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2240838 · Received August 16, 2011

    Report

    Report Number
    1723170-2011-01290
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. SUSPECT PSU/CAMERA, S/N (B)(4), RETURNED TO MFR. INVESTIGATION FINDS THE PSU TRACKED NORMALLY THROUGHOUT THE VOLUME DURING A FUNCTIONAL TEST. HOWEVER, THE PSU FAILED THE AAK TEST AT .74MM WITH NORMAL LINE SEPARATION OF 1.15MM. THE PSU IS OUT OF CALIBRATION.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED A POSITIONING SENSOR UNIT (PSU, OR CAMERA) NOT TRACKING PROPERLY. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE WAS NO IMPACT ON PT OUTCOME.

    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