BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 8709330 · Received June 18, 2019

    Report

    Report Number
    1723170-2019-03538
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    April 25, 2018
    Report Date
    June 18, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9734477, SERIAL/LOT #: (B)(4), UDI#: (B)(4); SOFTWARE (B)(4) STEALTHSTATION CRANIAL, UDI# (B)(4), 510K K153660. THIS DEVICE IS NOT APPROVED IN THE US, BUT IS SIMILAR TO A DEVICE MARKETED IN THE US WITH 510K K050438. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO INSPECT THE SYSTEM. THE COMPUTER WAS REPLACED AND THE ISSUE RESOLVED. THE COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED COMPUTER PASSED ALL TESTS AND THERE WAS NO FAILURE FOUND ON THE RETURNED PART. THE SOFTWARE INVESTIGATION WAS UNABLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. 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 SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT AFTER THE MICRO CALIBRATION WAS COMPLETED, THE OPERATION WAS CHECKED BY STARTING THE RELEVANT SOFTWARE APPLICATION. WHEN THE MAGNETIC INSTRUMENT WAS CONFIRMED, A NON-INVASIVE PATIENT TRACKER (NIPT) AND MALLEABLE SUCTIONS WERE NOT INDICATED. THE SOFTWARE APPLICATION WAS UNINSTALLED AND RE-INSTALLED. THE NIPT AND MALLEABLE SUCTIONS WERE INDICATED BUT WERE NOT INDICATED ON VERIFY INSTRUMENTS SCREEN. OPTICAL TYPE INSTRUMENT TOOL CARD COULD NOT BE ADDED AS WELL. MICRO LINK TOOL CARD ALSO FAILED TO BE ADDED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502297 CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1