BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 7894896 · Received September 20, 2018

    Report

    Report Number
    1723170-2018-04883
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    November 6, 2017
    Report Date
    September 21, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    SEE H10)
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE AXIEM PORTABLE SYSTEM AND THE EXTERNAL AXIEM PWR/DATA CABLE WERE REPLACED. A FULL SYSTEM CHECKOUT WAS PREFORMED AFTER THE PART REPLACEMENT AND ALL TESTS PASSED. THE AXIEM PORTABLE SYSTEM AND THE EXTERNAL AXIEM PWR/DATA CABLE WERE RETURNED. AFTER PHYSICAL EXAMINATION AND FUNCTIONAL TESTING NO FAILURE WAS FOUND WITH THE AXIEM PORTABLE SYSTEM. IT WAS FOUND THAT THERE WAS AN ELECTRICAL ISSUE WITH THE AXIEM PWR/DATA CABLE. NO MANUFACTURE DATE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE PROVIDED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT, ¿THE EMITTER WAS UNABLE TO BE ON-LINE THOUGH THE EM BOX.¿ NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734042 CART 9734056 S7 STAFF SHRT 100-120V INTL SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1