BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE GUIDED LASER ABLATION SYSTEM

    MDR report key: 8674242 · Received June 6, 2019

    Report

    Report Number
    1723170-2019-03016
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    January 24, 2019
    Report Date
    June 6, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    UDI-DI
    00643169655935
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS ASSOCIATED WITH A CLINICAL TRIAL ((B)(4)) CONDUCTED UNDER AN INVESTIGATIONAL DEVICE EXEMPTION (IDE). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED/SUBMITTED TO THE MANUFACTURER FOR AN EVALUATION TO BE CONDUCTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, FOLLOWING A SOFT NEURO TISSUE ABLATION PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE UNRESPONSIVENESS WITH VOICE AND PAINFUL STIMULI. IT WAS NOTED THAT AN INCREASED TONIC EXAM OF LE R>L OCCURRED. ADDITIONALLY, THE PATIENT'S FACE WAS NOTICED TO BE GRIMACED AND STIFF. AN ACTUAL SEIZURE WAS NOT OBSERVED DIRECTLY. AN IV OF LEVETIRACITAM AND AN IV OF LORAZEPAM WERE ADMINISTERED FOLLOWING THE REPORTED ISSUE. IT WAS NOTED THAT THE RELATEDNESS OF THE REPORTED ISSUE TO THE PROCEDURE WAS UNKNOWN AND THAT THE EVENT WAS NOT RELATED TO THE ABLATION SYSTEM USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468957 VISUALASE GUIDED LASER ABLATION SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542 00643169655935

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention