BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 7527325 · Received May 18, 2018

    Report

    Report Number
    1723170-2018-02142
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 19, 2018
    Report Date
    June 17, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    SEE H10)
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED DUE TO (B)(6) PATIENT PRIVACY REGULATIONS. NO PROCODE, COMMON DEVICE NAME AND/OR 510(K) PROVIDED AS THIS DEVICE IS NOT RELEASED FOR DISTRIBUTION IN THE UNITED STATES. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. PART NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE COMPUTER FOR THE NAVIGATION SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE COMPUTER WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. A SOFTWARE ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE THROUGH KNOWN ANOMALY DETERMINATION. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    CORRECTION: UPDATED WITH CORRECT PROCEDURE DELAY INFORMATION AND PATIENT OUTCOME; UPDATED WITH TRANSLATED PROCEDURE INFORMATION THIS DEVICE IS NOT APPROVED/MARKETED IN US, BUT IS SIMILAR TO A DEVICE MARKETED IN THE US UNDER K050438. 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 THE COMPUTER BECAME UNRESPONSIVE. THE ISSUE WAS RESOLVED BY RESTARTING THE COMPUTER.

    Description of Event or Problem · 1

    THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369877 CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10) HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1