BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11925893 · Received June 2, 2021

    Report

    Report Number
    1723170-2021-01472
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 2, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS ASSOCIATED WITH A CLINICAL TRIAL (B)(4) CONDUCTED UNDER AN INVESTIGATIONAL DEVICE EXEMPTION (IDE). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY BEING USED FOR NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT EXPERIENCED VOMITING. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT WHERE THEY HAD A COMPUTED TOMOGRAPHY (CT) OF THE HEAD, X-RAY OF THE CHEST, AND COVID-19 TESTING PERFORMED. ALL WERE UNREMARKABLE EXPECT THE CT SHOWED RIGHT MEDIAL TEMPORAL HYPODENSITY. THE PATIENT WAS GIVEN ZOFRAN IV AND REPORTED THAT THE VOMITING RESOLVED THE SAME DAY. IT WAS REPORTED THAT THE REPORTED EVENT WAS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815030 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention