BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGS

    MDR report key: 8665193 · Received June 3, 2019

    Report

    Report Number
    1723170-2019-02892
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 961578 FOUND A DAMAGED TOOL. THE HEAD OF THE ADJUSTMENT SCREW HAD TOOL MARKS ALL AROUND AND THE HEX HEAD WAS SLIGHTLY ROUNDED OUT ALLOWING SLIPPAGE OF THE TOOL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT SURETRAK MEDIUM WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458419 IGS INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 961578 141014

    Patients

    Seq Age Sex Outcome Treatment
    1