BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2092172 · Received April 27, 2011

    Report

    Report Number
    1723170-2011-00912
    Event Type
    Malfunction
    Date Received
    April 27, 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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. THE ISO C/STEALTHSTATION INTERFACE WAS SUCCESSFULLY RE-CALIBRATED AND TESTED PERFECTLY ACCURATE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING PLANNED MAINTENANCE FOR THE SITE'S STEALTHSTATION TREON, THE INTERFACE BETWEEN THE ISO C, (A NON-MEDTRONIC PRODUCT), AND THE STEALTHSTATION TREON WAS FOUND TO BE OUT OF CALIBRATION. THE CALIBRATION WAS INACCURATE BY 7MM LATERAL AND ANTERIOR. RE-CALIBRATION IS REQUIRED. THERE WAS NO PATIENT PRESENT. THE SYSTEM WAS NEVER USED IN A CASE WHEN IT WAS OUT OF CALIBRATION.

    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