BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE

    MDR report key: 10062077 · Received May 15, 2020

    Report

    Report Number
    1723170-2020-01439
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    October 9, 2018
    Report Date
    May 15, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. 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 · 1

    CITATION: ATILIO E. PALMA, MD, ROBERT T. WICKS, MD, GAUTAM POPLI, MD, AND DANIEL E. COUTURE, MD. CORPUS CALLOSOTOMY VIA LASER INTERSTITIAL THERMAL THERAPY: A CASE SERIES. J NEUROSURG PEDIATR 23:303¿307, 2019. DOI: 10.3171/2018.10.PEDS18368. HTTPS://THEJNS.ORG/DOI/ABS/10.31 71/2018.10.PEDS18368 CORPUS CALLOSOTOMY HAS BEEN USED AS A FORM OF SURGICAL PALLIATION FOR PATIENTS SUFFERING FROM MEDICALLY REFRACTORY GENERALIZED SEIZURES, INCLUDING DROP ATTACKS. CALLOSOTOMY HAS TRADITIONALLY BEEN DESCRIBED AS INVOLVING A CRANIOTOMY WITH MICRODISSECTION. MR-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRG-LITT) HAS RECENTLY BEEN USED AS A MINIMALLY INVASIVE METHOD FOR PERFORMING SURGICAL ABLATION OF EPILEPTOGENIC FOCI AND CORPUS CALLOSOTOMY. THE AUTHORS PRESENT 3 CASES IN WHICH MRG-LITT WAS USED TO PERFORM A CORPUS CALLOSOTOMY AS PART OF A STAGED SURGICAL PROCEDURE FOR A PATIENT WITH MULTIPLE SEIZURE TYPES AND IN INSTANCES WHEN FURTHER ABLATION OF RESIDUAL CORPUS CALLOSUM IS NECESSARY AFTER A PRIOR OPEN SURGICAL PROCEDURE. TO THE AUTHORS¿ KNOWLEDGE, THIS IS THE FIRST CASE SERIES OF CORPUS CALLOSOTOMY PERFORMED USING THE MRG-LITT SYSTEM WITH A 3.3-YEAR AVERAGE FOLLOW-UP. ALTHOUGHMRG-LITT IS NOT EXPECTED TO REPLACE THE TRADITIONAL CORPUS CALLOSOTOMY IN ALL CASES, IT IS A SAFE, EFFECTIVE, AND DURABLE ALTERNATIVE TO THE TRADITIONAL OPEN CORPUS CALLOSOTOMY, PARTICULARLY IN THE SETTING OF A PRIOR CRANIOTOMY. REPORTED EVENTS: A 13 MONTH OLD BOY EXPERIENCED INCREASED SEIZURE FREQUENCY THAT ULTIMATELY REACHED NEAR COMPLETE RESOLUTION OF CONVULSIVE SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526348 VISUALASE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Required Intervention