BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14090331 · Received April 12, 2022

    Report

    Report Number
    1723170-2022-00549
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Report Date
    April 12, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. EVENT DATE IS UNKNOWN AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT "IMPLANTS NAVIGATION IS NOT ALWAYS ACCURATE. NEED TO CONFIRM WITH FLUORO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662837 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS -

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown