BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE EMITTER FIELD GENERATOR

    MDR report key: 2974313 · Received February 22, 2013

    Report

    Report Number
    1723170-2013-00112
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE IS UNAVAILABLE AT THE TIME OF THIS REPORT, HOWEVER, HAS BEEN REQUESTED. RMA ISSUED. REPLACEMENT FIELD GENERATOR SHIPPED TO SITE (B)(4) 2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT WHEN THE FIELD GENERATOR WAS CONNECTED TO A TEST SYSTEM WITH THE CRANIAL APPLICATION, IT IMMEDIATELY DISPLAYED RED STATUS AND SAID "AXIEM EMITTER LOW DRIVE ERROR". PIN 35 TO PIN 36 ON CABLE (B)(4) (COIL #9) IS OPEN. ELECTRICAL ISSUE DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, OR RN, REPORTED THAT DURING AN ENT PROCEDURE, AFTER COMPLETING REGISTRATION AND PRIOR TO SELECTING "NEXT" TO NAVIGATE, THEY LOST COMMUNICATION WITH ALL INSTRUMENTS. THE EMITTER WAS STILL ON, BUT ALL INSTRUMENTS, EMITTER AND AXIEM BOX, WERE SHOWING COMMUNICATION ERROR IN THE TRACKING DETAILS. TROUBLE-SHOOTING DID NOT THE RESOLVE ISSUE. THE SURGEON OPTED TO CONTINUE THE PROCEDURE WITHOUT THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78392 MOBILE EMITTER FIELD GENERATOR NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR