BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2150583 · Received June 22, 2011

    Report

    Report Number
    1723170-2011-01136
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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. RMA ISSUED. EVALUATION OF THIS DEVICE HAS NOT BEEN PERFORMED AS OF THE DATE OF THIS REPORT. WHILE THIS ISSUE HAD NO IMPACT ON A PATIENT, IT IS BEING REPORTED DUE TO THE POSSIBILITY OF IT HAPPENING DURING A CASE WITHOUT BEING NOTICED, WHICH COULD CAUSE INCORRECT NAVIGATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAS A VERTEK ARM THAT WILL NO LONGER TIGHTEN. THIS WAS NOT DISCOVERED DURING SURGERY AND HAS NOT IMPACTED ANY CASES.

    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