BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2193515 · Received July 21, 2011

    Report

    Report Number
    1723170-2011-01252
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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. QUOTE FOR REPLACEMENT VERTEK ARM II PROVIDED TO SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE VERTEK ARM ON THE STEALTHSTATION TREON GUIDANCE SYSTEM WILL NOT LOCK DOWN. REQUESTED QUOTE FOR REPLACEMENT PART. THERE WAS NO PATIENT 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