BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION

    MDR report key: 9817583 · Received March 11, 2020

    Report

    Report Number
    1723170-2020-00840
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 11, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE MANUFACTURER REPRESENTATIVE REPLACED THE POSITIONING SENSOR UNIT (PSU). THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE PSU WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THE PSU FAILED DIAGNOSTIC TESTS. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A ELECTRICAL ISSUE. 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. IT WAS REPORTED THE ACCURACY ASSESSMENT KIT (AAK) TEST WAS FAILED. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278905 STEALTHSTATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1