BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10142551 · Received June 11, 2020

    Report

    Report Number
    1723170-2020-01637
    Event Type
    Death
    Date Received
    June 11, 2020
    Date of Event
    December 15, 2019
    Report Date
    June 11, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF DEATH NOT PROVIDED IN ARTICLE. THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM PRODUCT NUMBER AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: ALI H PALEJWALA, MD, KYLE P O¿CONNOR, BS, CAMILLE K MILTON, BS, PANAYIOTIS E PELARGOS, MD, CHAD A GLENN, MD, BRADLEY N BOHNSTEDT, MD, OZER ALGAN, MD, MICHAEL E SUGHRUE, MD, LASER INTERSTITIAL THERMAL THERAPY FOR METASTATIC MELANOMA AFTER FAILED RADIATION THERAPY: A CASE SERIES, OPERATIVE NEUROSURGERY, HTTPS://DOI.ORG/10.1093/ONS/OPAA012. SUMMARY: BACKGROUND: LASER INTERSTITIAL THERMAL THERAPY (LITT) IS A GROWING TECHNOLOGY TO TREAT A VARIETY OF BRAIN LESIONS. IT OFFERS AN ALTERNATIVE TO TREATMENT OPTIONS, SUCH AS OPEN CRANIOTOMY AND STEREOTACTIC RADIOSURGERY. OBJECTIVE: TO ANALYZE OUR EXPERIENCE USING LITT FOR METASTATIC MELANOMA. METHODS: THIS IS A RETROSPECTIVE CHART REVIEW OF THE PATIENTS FROM OUR INSTITUTION. OUR CASE SERIES INVOLVES 5 PATIENTS WHO HAD PREVIOUSLY FAILED RADIATION TREATMENT. RESULTS: OUR PATIENTS HAVE LOW COMPLICATION RATES AND SHORT HOSPITAL STAYS. BOTH ARE CONSIDERABLY LOWER WHEN COMPARED TO THE LITERATURE FOR METASTATIC MELANOMA. CONCLUSION: LITT IS A SAFE THERAPY, WITH FEW COMPLICATIONS AND SHORT HOSPITAL STAYS. REPORTED EVENTS: ONE (B)(6)-YEAR-OLD MALE WITH A HISTORY OF HISTORY OF MELANOMA WHO WAS FOUND TO HAVE A RIGHT FRONTAL AND CEREBELLAR INTRACRANIAL LESIONS UNDERWENT COMPLETE ABLATION TO A LESION VOLUME OF 0.296 CC WITH 1-FIBER LITT. THE PATIENT SPENT 5 DAYS IN THE HOSPITAL AND WAS DISCHARGED WITH A 10-DAY STEROID TAPER. THE PATIENT WAS KEPT FOR 5 DAYS BECAUSE HE HAD AN ISOLATED EPISODE OF ATRIAL FIBRILLATION. NO PERIOPERATIVE COMPLICATIONS WERE ENCOUNTERED. THE PATIENT DIED 21 MONTHS POST-LITT FROM COMPLICATION FORM EXTRACRANIAL DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607703 MEDTRONIC NAVIGATION LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death