BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1935913 · Received December 3, 2010

    Report

    Report Number
    1723170-2010-00127
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFORMATION PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A RMA WAS ISSUED FOR THE RETURN/REPLACEMENT OF THE PART.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REQUESTED A REPLACEMENT VERTEK ARM. THERE WAS NO PT 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 NONE