BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11372939 · Received February 24, 2021

    Report

    Report Number
    1723170-2021-00481
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    January 1, 2020
    Report Date
    February 24, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. EVENT DATE YEAR VALID, AS PUBLICATION WAS IN 2020. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE APPROVAL DATE OF THE ABSTRACT. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. POPULATED AS MEDTRONIC NAVIGATION, AS NO FACILITY WAS PROVIDED IN THE ABSTRACT. 510(K) UNPOPULATED AS THE VALUE IS DEPENDENT UPON THE DEVICE MODEL NUMBER. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: CANDELA S., HINOJOSA J., RUMIA J., MUNUERA J., MUCHART J., BECERRA M.V., SERRANO S., FORERO C., BORREGUERO F., ACERO S., PIFARRE F. REAL TIME MRI-GUIDED LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR HYPOTHALAMIC HAMARTOMA: A CASE SERIES STUDY AND MANAGEMENT STRATEGY. CHILD'S NERVOUS SYSTEM 2020 36: (2139). ABSTRACT: INTRODUCTION: TWENTY EIGHT (28) PATIENTS WITH EPILEPSY AND RECURRENT SEIZURES AND A DIAGNOSIS OF HYPOTHALAMIC HAMARTOMA (HH) HAVE BEEN TREATED IN THE PAST BY THE SENIOR AUTHOR (JH) USING DIFFERENT TECHNIQUES: MICROSURGERY, TRANSVENTRICULAR ENDOSCOPIC ASSISTED DISCONNECTION, AND RADIOSURGERY. REAL TIME MRI-GUIDED LASER INTERSTITIAL THERMAL THERAPY (LITT) HAS BEEN USED IN THE TREATMENT OF GLIOMAS, MESIAL SCLEROSIS OR VERY RECENTLY IN THE EU IN HYPOTHALAMIC HAMARTOMAS ABLATION. METHODS: THE VISUALASE THERMAL THERAPY SYSTEM (MEDTRONIC INC.) INTEGRATES A 15-W, 980-NM DIODE LASER AND COOLED LASER APPLICATOR SYSTEM WITH AN IMAGE-PROCESSING WORKSTATION TO PROVIDE FOR REAL-TIMEMRGLITT. 5 PATIENTS HAVE BEEN TREATED IN OUR INSTITUTION FROM APRIL TO OCTOBER 2019 WITH A DIAGNOSIS OF INTRACTABLE EPILEPSY AND HH. ALL OF THEM PRESENTED WITH GELASTIC AND/OR DACRISTIC SEIZURES TOGETHER WITH DIFFERENT TYPES OF GENERALIZED SEIZURES REFRACTORY TO MEDICAL TREATMENT. AGES RANGED FROM 5 TO 17 YEARS AND THEY ALL HARBORED HH TYPES II AND III ACCORDING TO THE DELALANDE CLASSIFICATION. PATIENTS WERE EVALUATED IN A MULTIDISCIPLINARY BASIS AT THE EPILEPSY SURGERY UNIT. TRAJECTORY WAS PLANNED WITH VOXIMTMSOFTWARE AND THE TARGET CENTERED ON THE LESION TO ACHIEVE COMPLETE DISCONNECTION FROM HYPOTHALAMUS AND MAMMILLARY BODIES. SCREW, CATHETER <(>&<)> FIBER INSERTION WAS ACHIEVED WITH THE NEUROMATE TM SURGICAL ROBOT. THERMAL ABLATION WAS PERFORMED UNDER REAL TIMEMR THERMOMETRY. AS AN AVERAGE , A TOTAL OF 6-10 ABLATIONS THROUGH 3-5 PULL-OUTS WERE DELIVERED. RESULTS: FOLLOW-UP VARIES FROM 2 TO 8 MONTHS . ALL PATIENTS ARE SEIZURE FREE. ONE PATIENT SUFFEREDA TRANSIENT MEMORY AND SEIZURE IMPAIRMENT (FIRST CASE). IN ONE PATIENT, THERE WAS A MINOR TRANSITORY HEMIPARESIS DUE TO WATER-PUMP FAILURE. CONCLUSION: LITT IS A SAFE PROCEDURE FOR THERMAL ABLATION IN SELECTED PEDIATRIC PATIENTS WITH HYPOTHALAMIC HAMARTOMAS. TYPE II AND III (DELALANDE) ARE BEST CANDIDATES ANTERIOR TRAJECTORIES ARE RECOMMENDED. LONG FOLLOW-UP IS NEEDED TO EVALUATE ITS OUTCOME AND EFFICACY. REPORTED EVENTS: ONE PATIENT SUFFERED A TRANSIENT MEMORY AND SEIZURE IMPAIRMENT. ONE PATIENT EXPERIENCED A MINOR TRANSITORY HEMIPARESIS DUE TO A WATER PUMP FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269112 MEDTRONIC NAVIGATION LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention