BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 15014456 · Received July 14, 2022

    Report

    Report Number
    1723170-2022-01099
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    March 25, 2022
    Report Date
    July 14, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH: PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. SEX: PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. WEIGHT: 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. 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 · 0

    CANDELA-CANTÓ, S., MUCHART, J., RAMÍREZ-CAMACHO, A., BECERRA, V., ALAMAR, M., PASCUAL, A., FORERO, C., POLO, M.R., MUNUERA, J., APARICIO, J., RUMIÀ, J., HINOJOSA, J. ROBOT-ASSISTED, REAL-TIME, MRI-GUIDED LASER INTERSTITIAL THERMAL THERAPY FOR PEDIATRIC PATIENTS WITH HYPOTHALAMIC HAMARTOMA: SURGICAL TECHNIQUE, PITFALLS, AND INITIAL RESULTS. JOURNAL NEUROSURGERY PEDIATRIC. 2022. 29 (681¿692) DOI: 10.3171/2022.2.PEDS21516 OBJECTIVE REAL-TIME, MRI-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRGLITT) HAS BEEN REPORTED AS A SAFE AND EFFECTIVE TECHNIQUE FOR THE TREATMENT OF EPILEPTOGENIC FOCI IN CHILDREN AND ADULTS. AFTER THE RECENT APPROVAL OF MRGLITT BY THE EUROPEAN MEDICINES AGENCY IN APRIL 2018, THE AUTHORS BEGAN TO USE IT FOR THE TREATMENT OF HYPOTHALAMIC HAMARTOMAS (HHS) IN PEDIATRIC PATIENTS WITH THE ASSISTANCE OF A ROBOTIC ARM. IN THIS STUDY, THE AUTHORS REPORT THEIR INITIAL EXPERIENCE DESCRIBING THE SURGICAL TECHNIQUE, ACCURACY OF THE ROBOTIC ARM, SAFETY, AND EFFICACY. METHODS THE LASER FIBER WAS PLACED WITH THE ASSISTANCE OF THE STEREOTACTIC ROBOTIC ARM. THE ACCURACY OF THE ROBOTIC ARM FOR THIS PRO CEDURE WAS CALCULATED BY COMPARING THE INTRAOPERATIVE MRI TO THE PREOPERATIVE PLAN. COMMON DEMOGRAPHIC AND SEIZURE CHARACTERISTICS OF THE PATIENTS, LASER ABLATION DETAILS, COMPLICATIONS, AND SHORT-TERM SEIZURE OUTCOMES WERE PROSPECTIVELY COLLECTED. RESULTS SIXTEEN PROCEDURES (11 FIRST ABLATIONS AND 5 REABLATIONS) WERE PERFORMED IN 11 PATIENTS BETWEEN 15 MONTHS AND 17 YEARS OF AGE (MEAN AGE 6.4 YEARS) WITH DRUG-RESISTANT EPILEPSY RELATED TO HHS. THE MEAN TARGET POINT LOCALIZATION ERROR WAS 1.69 MM. NO LASER FIBER NEEDED TO BE REPOSITIONED. THE MEAN LASER POWER USED PER PROCEDURE WAS 4.29 W. THE TRAJECTORY OF THE LASER FIBER WAS ACCIDENTALLY ABLATED IN 2 PATIENTS, PROVOKING TRANSIENT HEMIPARESIS IN ONE OF THESE PATIENTS. ONE PATIENT EXPERIENCED POSTOPERATIVE SOMNOLENCE AND SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION, AND 2 PATIENTS HAD TRANSIENT OCULOMOTOR (CRANIAL NERVE III) PALSY. FIFTY-FOUR PERCENT OF THE PATIENTS WERE SEIZURE FREE AFTER THE FIRST ABLATION (MEAN FOLLOW-UP 22 MONTHS, RANGE 15¿33 MONTHS). ALL 5 PATIENTS WHO EXPERIENCED AN EPILEPSY RELAPSE UNDERWENT A SECOND TREATMENT, AND 4 REMAIN SEIZURE FREE AT LEAST 5 MONTHS AFTER REABLATION. CONCLUSIONS IN THE AUTHORS¿ EXPERIENCE, THE ROBOTIC ARM WAS SUFFICIENTLY ACCURATE FOR LASER FIBER INSERTION, EVEN IN VERY YOUNG PATIENTS. MRGLITT APPEARS TO BE AN EFFECTIVE TREATMENT FOR SELECTED CASES OF HH. MRGLITT FOR HH IS A MINIMALLY INVASIVE PROCEDURE WITH APPEALING SAFETY FEATURES, AS IT ALLOWS DELIVERY OF ENERGY PRECISELY UNDER REAL-TIME MRI CONTROL. NONETHELESS, COMPLICATIONS MAY OCCUR, ESPECIALLY IN VOLUMINOUS HHS. THE AMOUNT OF DELIVERED ENERGY AND THE CATHETER COOLING SYSTEM MUST BE CLOSELY MONITORED DURING THE PROCEDURE. A LARGER SAMPLE SIZE AND LONGER FOLLOW-UP DURATION ARE NEEDED TO JUDGE THE EFFICACY AND SAFETY OF MRGLITT FOR HH MORE RIGOROUSLY. THIS INITIAL EXPERIENCE WAS VERY PROMISING. REPORTED EVENTS: PATIENTS 5, 6, 7, 9, AND 10 REQUIRED A SECOND TREATMENT IN WHICH TWO LASER FIBERS WERE USED TO ABLATE THE RESIDUAL HH. AFTER THE SECOND ABLATION, PATIENT 7 DEVELOPED SOMNOLENCE, SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (SIADH), AND HYPERPHAGIA, PROBABLY RELATED TO A SMALL LEFT HYPOTHALAMIC LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350000 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Required Intervention