BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3973642 · Received August 1, 2014

    Report

    Report Number
    1723170-2014-00806
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE STARBURST JOINT OF THE RETURNED ARTICULATING ARM WOULD NOT RELEASE OR LOCK DOWN COMPLETELY. THE REPORTED EVENT WAS CONFIRMED TO BE CAUSED BY A MECHANICAL ISSUE WITH THE ARTICULATING ARM MOST LIKELY DUE TO THE AGE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN.A REPLACEMENT DEVICE HAS BEEN SHIPPED TO THE SITE. A PROBABLE CAUSE WAS REPORTED TO BE USE/STERILIZATION PROCESS. HOWEVER, NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE REFERENCE FRAME ARM WAS DEFECTIVE BECAUSE IT DID NOT "FREEZE" PROPERLY. THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449917 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1