BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081108 · Received April 14, 2011

    Report

    Report Number
    1723170-2011-00791
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 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

    SOFTWARE INVESTIGATION COMPLETED. FINDINGS ARE THAT THERE IS AN ISSUE WITH HOW SNUG THE FRAME ATTACHMENT IS, RESULTING IN SLIGHT MOVEMENT. SOFTWARE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED PROBLEMS WITH TRACKING AFTER A SUCCESSFUL PATIENT REGISTRATION, IN AN ENT PROCEDURE. THE SITE USES AN OLD REFERENCE FRAME AND A PASSIVE PLANER BLUNT DURING PROCEDURES. THE MEDTRONIC REPRESENTATIVE STATED THE GEOMETRY ERROR IS BELOW TOLERANCE FOR BOTH THE FRAME AND THE INSTRUMENT AND BOTH ARE SEEN CLEARLY BY THE CAMERA. OBSERVATIONS ARE THAT NAVIGATION IS "CONSISTENTLY OFF 2MM TO THE LEFT" USING THIS METHOD. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PATIENT 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 63 YR