BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11069121 · Received December 23, 2020

    Report

    Report Number
    1723170-2020-03403
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    October 1, 2019
    Report Date
    December 23, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Adverse Event
    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. THE LITERATURE ARTICLE IS ATTACHED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ANESTHESIA FOR MRI-GUIDED LASER INTERSTITIAL THERMAL THERAPY (LITT) IN NEUROSURGERY: A RETROSPECTIVE SINGLE CENTER STUDY ALLAMPALLI V.; MATHEW J.; TOVAR-SPINOZA Z.; LI F.; GORJI R. JOURNAL OF NEUROSURGICAL ANESTHESIOLOGY (2019) 31:4 (477). DATE OF PUBLICATION: 1 OCT 2019 EMBASE LINK HTTPS://WWW.EMBASE.COM/SEARCH/RESULTS?SUBACTION=VIEWRECORD <(>&<)>ID=L629610187<(>&<)>FROM=EXPORT OBJECTIVE: DESCRIBE ANESTHETIC PRACTICE AND MANAGEMENT OF PATIENTS UNDERGOING MAGNETIC RESONANCE (MR)-GUIDED LASER INTERSTITIAL THERMAL THERAPY (LITT). INTRODUCTION: LITT WITH MR GUIDANCE HAS BEEN INCREASINGLY USED AS A MINIMALLY INVASIVE TREATMENT MODALITY FOR IN TRACRANIAL TUMORS AND REFRACTORY EPILEPSY. THE ADVENT OF THESE NEWER MODALITIES OF TREATMENT POSE UNIQUE CHALLENGES TO THE ANESTHESIOLOGISTS WHO PLAY AN INTEGRAL ROLE IN THE SAFE-CONDUCT OF THESE PROCEDURES. IN THIS RETROSPECTIVE STUDY WE REVIEWED PATIENT CASE RECORDS AND ANESTHESIA RECORDS OF PATIENTS WHO UNDERWENT MR-GUIDED LITT FOR INTRACRANIAL LESIONS (TUMOR/EPILEPSY) AT UPSTATE UNIVERSITY HOSPITAL AND UPSTATE CANCER CENTER FROM JANUARY 1, 2008 TO DECEMBER 4, 2018. RESULTS: DURING THE STUDY PERIOD, A TOTAL OF 69 PATIENTS (30 BRAIN TUMORS, 39 EPILEPSY) UNDERWENT MR-GUIDED LASER INDUCED THERMAL THERAPY. BASELINE CHARACTERISTICS OF PATIENTS WERE OBTAINED. TYPE OF ANESTHETIC TECHNIQUE AND MONITORING USED WAS TABULATED AND ANALYZED. ALL PATIENTS UNDERWENT GENERAL ANESTHESIA. INVASIVE BLOOD PRESSURE MONITORING WAS USED IN 14 PATIENTS. TWO TYPES OF LITT SYSTEMS WERE UTILIZED-VISUALASE SYSTEM (VISUALASE INC., HOUSTON, TX) IN 41 CASES AND THE NEUROBLATE SYSTEM (MONTERIS MEDICAL CORPORATION, PLYMOUTH, MN) IN 28 CASES. AVERAGE LASER TIME WAS 15 MINUTES 2 SECONDS. AVERAGE DURATION OF ANESTHESIA WAS 438 MINUTES. AVERAGE DURATION OF PACU (POST ANESTHESIA CARE UNIT) STAY WAS NOTED TO BE 57 MINUTES (N = 68). NO COMPLICATIONS WERE FOUND IN PACU, HOWEVER, 2 PATIENTS DEVELOPED CEREBRAL EDEMA LATER DURING HOSPITAL STAY. CONCLUSIONS: GENERAL ENDOTRACHEAL ANESTHESIA WITH VOLATILE AGENT FOR MAINTENANCE WAS THE ANESTHETIC TECHNIQUE OF CHOICE. WITH EVER-EXPANDING USE OF IMAGE GUIDED LASER THERMAL THERAPY, ANESTHESIOLOGISTS ARE EXPECTED TO BE FAMILIAR WITH THE TECHNOLOGY AND ANESTHETIC CONSIDERATIONS INVOLVED TO SAFELY MANAGE THE PATIENT AND FACILITATE SMOOTH CONDUCT OF THE PROCEDURE. REPORTED EVENTS: 1. 2 PATIENTS DEVELOPED CEREBRAL EDEMA DURING THE HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531093 MEDTRONIC NAVIGATION LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other