BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 8422569 · Received March 14, 2019

    Report

    Report Number
    1723170-2019-01116
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 18, 2019
    Report Date
    August 16, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THERE WAS A BREAK IN THE CABLE. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 961-339, SERIAL/LOT: (B)(4), UBD: , UDI: (B)(4). 2019-07-30. ANALYSIS OF THE RETURNED CRANIAL FRAME FOUND DAMAGE. WHEN CONNECTED TO A KNOWN GOOD SYSTEM, LED #3 WAS NOT FIRING. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A NAVIGATION SYSTEM BEING USED FOR A TUMORECTOMY. THE REP INDICATED THAT THE ACTIVE FRAME FRACTURED. THERE WAS A LESS THAN ONE HOUR DELAY IN PROCEDURE AS A RESULT, BUT THERE WAS NO CHANGE IN PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215942 CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1