BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12366695 · Received August 25, 2021

    Report

    Report Number
    1723170-2021-02143
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    December 30, 2020
    Report Date
    August 25, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE UNIQUE IDENTIFIER WAS NOT KNOWN AT THE TIME OF REPORTING. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MANUFACTURE DATE WAS NOT KNOWN AT THE TIME OF REPORTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MITHANI, K., NEUDORFER, C., BOUTET, A., GERMANN, J., ELIAS, G., WEIL, A., DONNER, E., KALIA, S., LOZANO, A., DRAKE J., WIDJAJA, E., IBRAHIM, J. SURGICAL TARGETING OF LARGE HYPOTHALAMIC HAMARTOMAS AND SEIZURE-FREEDOM FOLLOWING MR-GUIDED LASER INTERSTITIAL THERMAL THERAPY. EPILEPSY <(>&<)> BEHAVIOR. 116 (2021) 107774. DOI: HTTPS://DOI.ORG/10.1016/J.YEBEH.2021.107774 SUMMARY: BACKGROUND: LARGE HYPOTHALAMIC HAMARTOMAS (HH) ARE OFTEN ASSOCIATED WITH DIFFICULT-TO-TREAT, REFRACTORY SEIZURES. ALTHOUGH MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRGLITT) HAS EMERGED AS A USEFUL TOOL TO TREAT THESE CHALLENGING LESIONS, POST OPERATIVE OUTCOMES ARE VARIABLE AND POTENTIALLY RELATED TO DIFFERENCES IN SURGICAL TARGETING. PURPOSE: WE SOUGHT TO IDENTIFY DIFFERENCES IN THE ANATOMIC LOCALIZATION OF LASER ABLATIONS THAT EITHER DID OR DID NOT RESULT IN SEIZURE FREEDOM. METHODS: FOUR CHILDREN WHO UNDERWENT MRGLITT FOR LARGE HH (3 SEIZURE-FREE AND 1 NOT SEIZURE-FREE) WERE INCLUDED IN THE ANALYSIS. ABL ATION VOLUMES WERE SEGMENTED, NORMALIZED, AND OVERLAID ON A HIGH RESOLUTION HYPOTHALAMIC ATLAS. FOR EACH LESION, THE SIZE, SPATIAL EXTENT, AND DEGREE OF OVERLAP WITH KEY HYPOTHALAMIC NUCLEI AND SURROUNDING BRAIN REGIONS WERE COMPUTED AND COMPARED BETWEEN ABLATIONS THAT DID AND DID NOT RESULT IN SEIZURE FREEDOM. RESULTS: ABLATION MASKS THAT RESULTED IN SEIZURE FREEDOM WERE SMALLER AND LOCATED MORE CENTRALLY THAN THE ABLATION MASK THAT DID NOT. IN ADDITION, ABLATION MASKS THAT RESULTED IN SEIZURE FREEDOM OVERLAPPED WITH REGIONS INCLUDING THE PARAVENTRICULAR NUCLEUS, THE POSTERIOR HYPOTHALAMUS AND THE ZONA INCERTA, FORNIX, AND MAMMILLOTHALAMIC TRACT, WHEREAS THE SINGLE NON-SEIZURE-FREE ABLATION DID NOT. CONCLUSION: DIFFERENCES IN THE SIZE, POSITION, AND ANATOMICAL LOCALIZATION OF ABLATION VOLUMES MAY BE A POTENTIAL CONTRIBUTOR TO THE VARIABILITY IN POSTOPERATIVE OUTCOMES OF LARGE HH TREATED WITH MRGLITT. A NOVEL, HIGH-RESOLUTION MRI ATLAS OF THE HYPOTHALAMUS IDENTIFIES A NUMBER OF REGIONS AT THE INTERFACE OF LARGE HH THAT ARE PREFERENTIALLY DISCONNECTED IN SEIZURE-FREE PATIENTS. THIS METHOD OF ANATOMICAL LOCALIZATION NOT ONLY SERVES AS A POTENTIAL CLINICAL TOOL FOR SURGICAL TARGETING BUT MAY ALSO PROVIDE NOVEL INSIGHTS INTO THE MECHANISMS OF EPILEPTOGENESIS IN HYPOTHALAMIC HAMARTOMAS. REPORTED EVENTS: ONE PATIENT WAS ASYMPTOMATIC, WITH MILD GLUCOSURIA AND PYURIA. TRANSIENT OCCURRENCE OF INTERMITTENT ¿¿SCREAMING SPELLS¿ THAT SELF-RESOLVED WITHIN 3 MONTHS. ONE PATIENT WITH MINOR SYMPTOMS. SUPERFICIAL WOUND INFECTION, WITH SOME RESIDUAL ALOPECIA. SOME EPISODES OF INTERMITTENT ANGER AND IRRITATION, THOUGHT TO BE RELATED TO AEDS. ONE PATIENT WITH MILD AND TRANSIENT DROWSINESS THAT SPONTANEOUSLY RETURN TO NEUROLOGICAL BASELINE WITHIN THE SPAN OF DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264919 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other