BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE CRANIAL REFERENCE FRAME

    MDR report key: 8258793 · Received January 17, 2019

    Report

    Report Number
    1723170-2019-00316
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 26, 2018
    Report Date
    May 30, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169545588
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FRAME 9733881 CRANIAL ACTIVE HC (LOT# 150929) WAS RETURNED AND ANALYSIS FOUND AN ELECTRICAL FAILURE. WHEN CONNECTED TO A KNOWN GOOD SYSTEM NONE OF THE LEDS WERE FIRING. THE FRAME ALSO DID NOT DISPLAY A LIGHTED STATUS ON THE TIU INDICATING A LIKELY OPEN IN THE CABLE. 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.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 OF PROCEDURE. IT WAS REPORTED THAT THE SMALL CRANIAL ACTIVE FRAME LONG CABLE HAD A RECOGNITION FAILURE. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51044 ACTIVE CRANIAL REFERENCE FRAME INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733881 150929 00643169545588

    Patients

    Seq Age Sex Outcome Treatment
    1