BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 16585023 · Received March 21, 2023

    Report

    Report Number
    1723170-2023-00433
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    September 1, 2022
    Report Date
    March 21, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT SEX NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    CANDELA-CANTÓ S., RUMIÀ J., MUCHART J., ALAMAR M., CULEBRAS D., BECERRA V., ARMERO G., DOMÍNGUEZ J., PASCUAL A., ARTÉS D., APARICIO J., HINOJOSA J. REAL-TIME MRI THERMOGRAPHY-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRIGLITT) FOR HYPOTHALAMIC HAMARTOMAS IN PEDIATRIC PATIENTS STEREOTACTIC FUNCTION NEUROSURGERY. 2022. 100: (24). HTTPS://DOI.ORG/10.1159/000526735 ABSTRACT OBJECTIVES: AFTER ITS APPROVAL BY THE EUROPEAN MEDICINES AGENCY (EMA) IN APRIL 2018, WE HAVE INCORPORATED MRI THERMOGRAPHY-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRIGLITT) FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH REFRACTORY EPILEPSY. THE MOST FREQUENT INDICATION IN OUR PATIENTS HAS BEEN HYPOTHALAMIC HAMARTOMA (HH). WE PRESENT OUR CURRENT EXPERIENCE WITH THIS INDICATION. METHODS: THE VISUALASE® SYSTEM (MEDTRONIC®) HAS BEEN USED WITH THE NEUROMATE® ROBOTIC ARM (RENISHAW®). THE DEMOGRAPHIC AND EPILEPSY CHARACTERISTICS OF THE PATIENTS, THE PRECISION OF THE ROBOT, DETAILS OF THE LASER ABLATION, COMPLICATIONS AND SHORT-TERM RESULTS HAVE BEEN COLLECTED. RESULTS: NINETEEN PROCEDURES (14 FIRST TREATMENTS AND 5 REOPERATIONS) HAVE BEEN PERFORMED IN 14 PATIENTS BETWEEN 15 MONTHS AND 18 YEARS OF AGE (7 YEARS ON AVERAGE) WITH EPILEPSY REFRACTORY TO MEDICAL TREATMENT SECONDARY TO HH. THE MEAN TARGET POINT LOCALIZING ERROR (TPLE) WAS 1.6 +/ 0.9 MM. NO LASER FIBER HAD TO BE REPOSITIONED. AN ACCIDENTAL ABLATION OF THE TRAJECTORY OCCURRED IN 2 PATIENTS, CAUSING TRANSIENT HEMIPARESIS IN ONE OF THEM; ONE PATIENT PRESENTED POSTOPERATIVE DROWSINESS AND TWO TRANSIENT THIRD NERVE PALSY. 9 OF THE PATIENTS (64%) WERE SEIZURE-FREE AFTER THE FIRST ABLATION WITH A MEAN FOLLOW-UP OF 23.5 MONTHS (3-37 MONTHS). THE OTHER 5 PATIENTS WERE TREATED A SECOND TIME AFTER EPILEPSY RECURRENCE AND 4 OF THEM ARE ALSO SEIZURE- FREE WITH A MINIMUM FOLLOW-UP OF 7 MONTHS. 93% OF OUR PATIENTS ARE CURRENTLY SEIZURE-FREE. CONCLUSIONS: THE ROBOTIC ARM HAS BEEN PRECISE ENOUGH FOR THE INSERTION OF THE LASER FIBER. MRIGLITT APPEARS TO BE AN EFFECTIVE TREATMENT IN SELECTED PATIENTS WITH HH. HOWEVER, COMPLICATIONS CAN OCCUR, ESPECIALLY IN LARGE HAMARTOMAS AND AT THE BEGINNING OF THE LEARNING CURVE. REPORTED EVENTS: ONE PATIENT PRESENTED POSTOPERATIVE DROWSINESS TWO PATIENT HAD TRANSIENT THIRD NERVE PALSY 5 PATIENTS WERE TREATED A SECOND TIME AFTER EPILEPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361721 VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC 9735542

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown