BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 9369188 · Received November 25, 2019

    Report

    Report Number
    1723170-2019-05750
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 17, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 973120 ; PRODUCT ID: 9660651. NO PMA/510K AS THIS EVENT OCCURRED ON A SYSTEM THAT IS NOT MARKETED IN THE UNITED STATES, BUT IS BEING REPORTED AS A SIMILAR DEVICE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE MANUFACTURER REPRESENTATIVE REPLACE THE EMITTER AND THE ELECTROMAGNETIC LOCALIZATION SYSTEM. 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

    THE FIELD GENERATOR AND THE ELECTROMAGNETIC LOCALIZATION SYSTEM WERE BOTH RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE FIELD GENERATOR AND THE ELECTROMAGNETIC LOCALIZATION SYSTEM WERE BOTH FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A CRANIAL BIOPSY, THE ELECTROMAGNETIC NAVIGATION FIELD WAS NOT RECOGNIZED AS THE NAVIGATION SYSTEM DISPLAYED LOCALIZER WAS NOT CONNECTED. DISCONNECTING AND RE-CONNECTING THE UNIT SEVERAL TIMES DID NOT RESTORE FUNCTIONALITY. ADDITIONALLY THE NAVIGATION SYSTEM WAS REBOOTED WITHOUT RESOLUTION. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164066 CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1