BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGHTER SURETRAK II UNIVERSAL TRACKER, LARGE PASSIVE

    MDR report key: 8888087 · Received August 13, 2019

    Report

    Report Number
    1723170-2019-04462
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 16, 2019
    Report Date
    August 13, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00721902672309
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE ARRAY 961581 SURETRAK2 LARGE PASSIVE (LOT# 130424) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE RETURNED TRACKER WAS FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. THE TRACKER WAS ABLE TO ATTACH TO A CLAMP WITHOUT ISSUE. WITH MARKERS ATTACHED AND FULLY SEATED, THE TRACKER RETURNED GOOD GEOMETRY ERROR WITH NORMAL TRACKING. THERE WAS NO FAULT FOUND WITH THE DEVICE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. 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 DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A DAMAGED BLACK SURETRAK. THIS WAS DISCOVERED DURING SET-UP AND NO PATIENT WAS PRESENT. THE ORANGE SURTRAK WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680401 FIGHTER SURETRAK II UNIVERSAL TRACKER, LARGE PASSIVE INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 961581 130424 00721902672309

    Patients

    Seq Age Sex Outcome Treatment
    1