BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2220088 · Received August 9, 2011

    Report

    Report Number
    1723170-2011-01271
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 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

    NO PT INFO PROVIDED AS NO PT WS INVOLVED IN THIS CONCERN. INITIAL TROUBLESHOOTING DID NOT SOLVE THE ISSUE. WIRELESS TRACKER WAS REPLACED AS CALIBRATION WAS >3 FEET OFF. MEDTRONIC REP REPORTED ON (B)(6) 2011 THAT THE NEW TRACKER WAS INSTALLED AND CALIBRATED. THE NEW CALIBRATION WAS SUCCESSFUL AND THE OLD TRACKER HAS BEEN SENT BACK TO THE MFR. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED DIFFICULTY ACQUIRING ORBIC EXAMS WITH THE STEALTHSTATION TREON GUIDANCE SYSTEM. THERE WAS 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