BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11064734 · Received December 23, 2020

    Report

    Report Number
    1723170-2020-03385
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    January 1, 2014
    Report Date
    December 23, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INCLUDES THE ARTICLE CITATION. LITERATURE ARTICLE ATTACHED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    COMPLICATIONS OF MR-GUIDED STEREOTACTIC LASER ABLATION OF HYPOTHALAMIC HAMARTOMAS IN THE TREATMENT OF INTRACTABLE GELASTIC EPILEPSY IN CHILDHOOD; A MULTI-CENTER STUDY CURRY D.; WILFONG A.; TOVAR-SPINOZA Z.; MADSEN J.; TAKEOKA M.; YOSHOR D.; VISWANATHAN A.; OJEMANN J. EPILEPSY CURRENTS (2014) 14 SUPPL. 1 (449). DATE OF PUBLICATION: JANUARY-FEBRUARY 2014 EMBASE LINK HTTPS://WWW.EMBASE.COM/SEARCH/RESULTS?SUBACTION=VIEWRECORD <(>&<)>ID=L71433784<(>&<)>FROM=EXPORT RATIONALE: HYPOTHALAMIC HAMARTOMA IS A RARE BUT DISABLING EPILEPTIC SYNDROME THAT IMPARTS SEVERE REFRACTORY GELASTIC SEIZURES, FREQUENTLY PRESENTING WITH EPILEPTIC ENCEPHALOPATHY. SURGERY TO CURE GELASTIC SEIZURES HAS TRADITIONALLY BEEN OPEN AND HIGHLY MORBID. RECENTLY MINIMALLY INVASIVE TECHNIQUES HAVE DESIGNED TO DECREASE OPERATIVE MORBIDITY. WE PRESENT THE SAFETY PROFILE OF THE MULTI-CENTER EXPERIENCE OF THE USE OF MR-GUIDED STEREOTACTIC LASER THERMOABLATION (SLA) IN THE TREATMENT OF HYPOTHALAMIC HAMARTOMA. METHODS: 23 PEDIATRIC PATIENTS FROM FIVE EPILEPSY CENTERS PRESENTED WITH INTRACTABLE EPILEPSY ASSOCIATED WITH HYPOTHALAMIC HAMARTOMA. AN IRB APPROVED PROTOCOL WAS FOR PEDIATRIC PATIENTS (2-18 Y.O.) WITH MEDICALLY INTRACTABLE, FOCAL, LESIONAL EPILEPSY. AN FDA-CLEARED SURGICAL LASER ABLATION SYSTEM (VISUALASE THERMAL THERAPY SYSTEM; VISUALASE, INC., HOUSTON, TX) WAS EMPLOYED IN THIS WORK. THE COOLED LASER APPLICATOR IS MR-COMPATIBLE (1.6MM IN DIAMETER) WITH A CENTRAL 400-¿M CORE SILICA FIBEROPTIC APPLICATOR WITH 1 CM AND 3 MM LIGHTDIFFUSING TIPS. FRAMED AND FRAMELESS STEREOTAXY WAS USED TO NAVIGATE THE LASER APPLICATOR TO THE TARGETED FOCI. MAGNETIC RESONANCE TEMPERATURE IMAGING (MRTI) WAS USED TO TEST DOSE AT 3-4W FOR 15-45 SECONDS TO CONFIRM APPLICATOR POSITION, DOSES OF 5-8W FOR 45-120 SECONDS WERE USED TO ABLATE THE FOCI. SAFETY LIMITS (50°C) WERE PLACED NEAR THE MARGIN OF THE DESIRED THERMAL ABLATION ZONE TO PROTECT CRITICAL STRUCTURES LIKE THE OPTIC TRACT, FORNIX AND MAMMALOTHALAMIC TRACT. AFTER COMPLETION OF THE ABLATION PROCEDURE, POST ABLATION T1- WEIGHTED PLUS GADOLINIUM CONTRAST (T1 + GD) AND DWI SERIES WERE ACQUIRED. FOLLOW-UP PERIOD WAS FROM 1-32MONTHS RESULTS: SEIZURE FREEDOM WAS OBTAINED IN 81% OF THE PATIENTS. OF THE TEN PATIENTS THAT ARE MORE THAN ONE YEAR POST-ABLATION, 9 ARE SEIZURE FREE. IN THE 13 PATIENTS WITH <(><<)> 1 YEAR FOLLOW-UP, 10 ACHIEVED SEIZURE FREEDOM AND 3HAD SEIZURE REDUCTION. THREE PATIENTS ACHIEVED SEIZURE FREEDOM AFTER 2ND PROCEDURE NO PERMANENT SURGICAL COMPLICATIONS (DI, MEMORY IMPAIRMENT, HORMONAL CHANGES, HEMIPARESIS, VISUAL CHANGES) WERE NOTED. ONE PATIENT HAS TRANSIENT SHORT-TERM MEMORY LOSS, HYPERTHERMIA AND HYPERPHAGIA PRIOR TO THE INSTITUTION OF PREABLATION HIGH DOES STEROIDS. THERE WAS A SINGLE INCIDENT OF SUBCLINICAL SUBARACHNOID HEMORRHAGE; THERE WERE TWO EPISODES OF TRANSIENT HEMIPARESIS, AND THREE EPISODES OF TRANSIENT SHORT-TERM MEMORY DEFICIT. THERE WERE THREE TARGET INACCURACIES, ONE WITH A RIGID FRAME, TWO WITH A FRAMELESS SYSTEM. THERE WAS ONE SUBGALEAL CSF COLLECTION. AVERAGE LOS WAS 2.15 DAYS. CONCLUSIONS: MR-GUIDED SLA FOR HYPOTHALAMIC HAMARTOMAS APPEARS TO BE A SAFE AND EFFECTIVE ALTERNATIVE TO OPEN SURGICAL RESECTION IN CHILDREN WITH INTRACTABLE EPILEPSY. REAL-TIME, FEEDBACKCONTROLLED ABLATION WITHIN THE MR SCANNER, ALONG WITH THE MINIMALLY INVASIVE APPROACH, LIKELY CONTRIBUTED TO THE LOW MORBIDITY. REPORTED EVENT(S): THERE WERE 3 TARGET INACCURACIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529562 MEDTRONIC NAVIGATION LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1