BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2152192 · Received June 23, 2011

    Report

    Report Number
    1723170-2011-01143
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 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

    MEDTRONIC INVESTIGATION FINDS THAT NAVIGATION WAS ABORTED AFTER THE SKIN INCISION WAS MADE BUT PRIOR TO THE BONE FLAP, AS THE PATIENT TRACKER SHIFTED DUE TO THE SIZE OF THE INCISION AND THE SKIN SHIFTING.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SITE ALLEGED AN INACCURACY WHILE IN A CRANIAL PROCEDURE. THE SURGEON DISCONTINUED USE OF THE STEALTHSTATION TREON GUIDANCE SYSTEM TO COMPLETE THE SURGERY. 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 UNK