BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9733856 S7 STAFF ASSEMBLED 110V

    MDR report key: 8704380 · Received June 17, 2019

    Report

    Report Number
    1723170-2019-03450
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 21, 2019
    Report Date
    December 27, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER SOFTWARE ANALYSIS WAS PERFORMED. IT WAS DETERMINED THAT THE SOFTWARE AND SYSTEM WERE FUNCTIONING AS DESIGNED. THE ISSUE WAS NOTED TO BE CAUSED BY USER ERROR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A SOFTWARE ANALYSIS WAS CONDUCTED AS PART OF THE INVESTIGATION. THE ANALYSIS FOUND THAT THE BEHAVIOR WAS CONSISTENT WITH A KNOWN ANOMALY IN THE MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ON-SITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. THE SYSTEM PASSED A SYSTEM CHECKOUT AND WAS DETERMINED THE FULLY OPERATIONAL. 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 FOR A TUMOR RESECTION PROCEDURE. IT WAS REPORTED THAT DURING REGISTRATION THE SITE DID TOUGH-N-GO REGISTRATION WHICH YIELDED A 2.3 MM METRIC. HOWEVER, UPON STARTING NAVIGATION THE ANATOMY WAS FLIPPED. THE SITE RE-REGISTERED THE PATIENT USING POINT MERGE AND WERE ABLE TO OBTAIN A SUCCESSFUL REGISTRATION. THE SURGICAL DELAY WAS 15-20 MINUTES AND NO REPORTED IMPACT TO PATIENT OUTCOME. TECHNICAL SERVICES (TS) NOTED THE MOST LIKELY ISSUE WAS SYMMETRICAL FIDUCIAL WERE OBSERVED AND WAS THE PROBABLE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498207 CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR