BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1910557 · Received November 19, 2010

    Report

    Report Number
    1723170-2010-00092
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHEN THEY PLUGGED IN THE AXIEM EMITTER, THE SYSTEM WAS SLOW. HARD DRIVE WAS 40% FULL. THE PATIENT WAS INTUBATED, AND THE SURGEON CHOSE NOT TO CONTINUE THE SURGERY DUE TO THE ISSUE. THE SURGERY WAS RESCHEDULED FOR (B)(6) 2010. THE EMITTER WAS REPLACED, SYSTEM TESTED AND CASE COMPLETED WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEROTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention