BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2884123 · Received December 21, 2012

    Report

    Report Number
    1723170-2012-00773
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON WHILE PERFORMING A TRANSPHENOIDAL TUMOR RESECTION BUMPED THE DYNAMIC REFERENCE FRAME (DRF) RESULTING IN AN INACCURACY. IT DID NOT FALL OFF THE PATIENT, BUT NAVIGATION WAS SUFFICIENTLY INACCURATE AND WAS DISCONTINUED. THERE WAS NO REPORTED NEGATIVE IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR