BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE EMITTER FIELD GENERATOR

    MDR report key: 2922586 · Received January 18, 2013

    Report

    Report Number
    1723170-2013-00035
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. REPLACEMENT DEVICE SHIPPED TO SITE (B)(4) 2013. MEDTRONIC REPRESENTATIVE, AT THE SITE, TESTED THE SYSTEM WITH THE DAMAGED EMITTER AND THE REPLACEMENT EMITTER - BOTH HAVE SAME RANGE AND ARE TRACKING THE SAME. NO ISSUES WITH TRACKING OR ACCURACY. MEDTRONIC MANUFACTURER EVALUATION OF RETURNED SUSPECT DEVICE FINDS THE FIELD GENERATOR NAVIGATES NORMALLY IN THE ENT APPLICATION WITH ALL COILS IN GREEN STATUS. IT PASSED THE PEGBOARD TEST WITH AN ERROR OF 1.413MM AND DETERMINED TO BE FULLY FUNCTIONAL. THIS SUSPECT EMITTER IS BEING SCRAPPED AS A PRECAUTION SINCE IT WAS DROPPED AFTER REGISTRATION DURING A MEDICAL CASE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOW PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT DURING AN ENT PROCEDURE, THE SITE DROPPED THE EMITTER AFTER REGISTRATION. THE SITE STATED THAT THE EMITTER WAS DROPPED [FROM PRETTY HIGH UP]. THE SURGEON ALLEGED AN INACCURACY HAD RESULTED FROM THE INCIDENT, HOWEVER, OPTED TO CONTINUE THE PROCEDURE WITH THE USE OF THE FUSION NAVIGATION SYSTEM TO COMPLETION. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27408 MOBILE EMITTER FIELD GENERATOR NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR