BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3180556 · Received June 20, 2013

    Report

    Report Number
    1723170-2013-00461
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. REPLACEMENT VERTEK ARM SHIPPED TO SITE. RETURN OF SUSPECT DEVICE TO MANUFACTURER FOR EVALUATION IS NOT EXPECTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A VERTEK ARM THAT DOES NOT LOCK PROPERLY. THIS WAS IDENTIFIED WHILE IN STERILE PROCESSING. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280329 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1