BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2973075 · Received February 21, 2013

    Report

    Report Number
    1723170-2013-00106
    Event Type
    Malfunction
    Date Received
    February 21, 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
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. REPLACEMENT AXIEM COMMUNICATION CABLE SHIPPED TO SITE (B)(4) 2013. REPLACEMENT AXIEM INTEGRATED 4PORT SHIPPED TO SITE (B)(4) 2013. A MEDTRONIC REPRESENTATIVE, TROUBLE-SHOOTING AT THE SITE WITH THE REPORTING NURSE, REMOVED SUSPECT CABLE AND AXIEM 4PORT AND INSTALLED REPLACEMENT DEVICES TO RESOLVE THE ISSUE. SUSPECT DEVICES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    THE AXIEM 4 PORT INTEGRATED SYSTEM WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION. ELECTRICAL EVALUATION PERFORMED FINDING THE AMBER FAULT LED IS ON CONTINUOUSLY. THE CRANIAL APPLICATION SHOWS RED STATUS AND DISPLAYS ERROR "AXIEM EMITTER LOW DRIVE ERROR". DIAGNOSTICS SHOWS A FAULT LIGHT ON ALL 9 COILS ON THE TRANSMITTER COIL ARRAY (TCA) DRIVE CURRENT LINE.

    Description of Event or Problem · 1

    A SITE NURSE REPORTED THAT AT THE END OF A FRONTAL ENDOSCOPIC SINUS SURGERY (FESS) THAT THE SCREEN BECAME UNRESPONSIVE AND THE CROSSHAIRS WENT RED. WHEN THEY PULLED UP TRACKING DETAILS, THE EMITTER AND AXIEM BOX SHOWED A COMMUNICATION ERROR. AS A SYSTEM RE-BOOT DID NOT RESOLVE THE ISSUE, THE SURGEON OPTED TO COMPLETE 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
    76773 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR