BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 4232864 · Received November 6, 2014

    Report

    Report Number
    1723170-2014-01199
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE CONTACT INFORMATION FOR THE SPECIFIC PERSON WHO REPORTED THIS EVENT WAS UNAVAILABLE. INITIAL REPORTER IS REPORTED AS THE CLINICAL ENGINEERING DEPARTMENT AT THE SITE FACILITY. REPLACEMENT DEVICE SHIPPED TO SITE FOR ISSUE RESOLUTION. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS AS THE PART HAS BEEN DISCARDED BY THE SITE.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE NAVIGATION SYSTEM VERTEK ARM WAS BROKEN AND COULD NOT BE TIGHTENED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714033 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1