BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION

    MDR report key: 8961120 · Received September 4, 2019

    Report

    Report Number
    3003084417-2018-00002
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    June 4, 2018
    Report Date
    July 16, 2018
    Manufacturer
    STEREOTAXIS, INC
    Product Code
    NDQ
    PMA / PMN Number
    K060967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE "SERIOUS INJURY" WAS SELECTED UNDER TYPE OF REPORTABLE EVENT DUE TO THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR 30MIN WHILE THE TROUBLESHOOTING OCCURED.

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR AN ABLATION PROCEDURE. THE PATIENT WAS PLACED ON THE TABLE AND GENERAL ANESTHESIA WAS ADMINISTERED. DURING SET UP OF THE NIOBE SYSTEM, AN ERROR OCCURRED WHILE ATTEMPTING TO HOME THE SYSTEM. THE SITE CONTACTED THE REMOTE SERVICE CENTER FOR TROUBLESHOOTING. A SERIES OF TROUBLESHOOTING ACTIVITIES WERE ATTEMPTED, AND AFTER 30 MINUTES, THE MAGNETIC PROCEDURE USING THE NIOBE SYSTEM WAS ABANDONED, AND THE PHYSICIAN OPTED TO PERFORM THE PROCEDURE MANUALLY. THE PATIENT HAD NO INJURY, HOWEVER WAS UNDER GENERAL ANESTHESIA FOR 30 MINUTES WHILE THE TROUBLESHOOTING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753579 NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION NIOBE NDQ STEREOTAXIS, INC 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other