BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 6432969 · Received March 24, 2017

    Report

    Report Number
    1723170-2017-01344
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    October 6, 2016
    Report Date
    March 24, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    UDI-DI
    00643169655935
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WEIGHTS ARE PROVIDED BY THE AUTHOR(S). IVAN, MICHAEL E., ROBERTO JOSE DIAZ, MICHAEL H. BERGER, GREGORY W. BASIL, DAVID A. OSIASON, THOMAS PLATE, AMANDA WALLO, AND RICARDO J. KOMOTAR. "MAGNETIC RESONANCE¿GUIDED LASER ABLATION FOR THE TREATMENT OF RECURRENT DURAL-BASED LESIONS: A SERIES OF FIVE CASES." WORLD NEUROSURGERY 98 (2016): 162-70. WEB. NO ALLEGATION OF ACTUAL MALFUNCTION OR INACCURACY OF TISSUE ABLATION OCCURRING. ARTICLE STATES THAT NO ADVERSE EVENTS RELATED TO THE VISUALASE SYSTEM OR THE PROCEDURE OCCURRED. NO REQUESTS FOR SYSTEM SERVICE HAVE BEEN RECEIVED FROM THE SITE REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    PER ATTACHED JOURNAL ARTICLE ENTITLED, MAGNETIC RESONANCEEGUIDED LASER ABLATION FOR THE TREATMENT OF RECURRENT DURAL-BASED LESIONS: A SERIES OF FIVE CASES BY IVAN ET AL, IT IS STATED: "IT REMAINS TO BE DETERMINED WHETHER THE CELL DEATH ESTIMATES GENERATED BY THE VISUALASE SYSTEM, WHICH WAS DESIGNED FOR PARENCHYMAL BRAIN LESIONS, REFLECTS ACCURATELY THE CELL DEATH INDUCED IN MENINGIOMA TISSUE BY A GIVEN TEMPERATURE AND TIME. THE DAMAGE ESTIMATE GENERATED BY THE CURRENT SOFTWARE MAY NOT BE AN ACCURATE REFLECTION OF CELLULAR DAMAGE. CHANGES IN MRI SIGNAL AND CONTRAST ENHANCEMENT AFTER THERMAL ABLATION SUGGEST ALTERATIONS IN WATER CONTENT, NECROSIS, AND VESSEL COAGULATION; HOWEVER, THESE CHANGES MUST BE FURTHER VALIDATED WITH DETAILED HISTOLOGIC EXAMINATION." IT IS ALSO STATED THAT, " NO PATIENT EXPERIENCED TRANSIENT WORSENING OF SYMPTOMS IN THE PERIOPERATIVE PERIOD OR PERMANENT SIDE EFFECTS FROM THE ABLATIVE PROCEDURE. ALL 5 PATIENTS WERE DISCHARGED HOME AFTER THE PROCEDURE ON POSTOPERATIVE DAY ONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214207 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 00643169655935

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR