BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2152443 · Received June 28, 2011

    Report

    Report Number
    1723170-2011-01169
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. TROUBLESHOOTING CONFIRMED PROBLEM WITH THE MONITOR. REPLACEMENT MONITOR SHIPPED ON (B)(4) 2011, THIS RESOLVED THE ISSUE. NO FURTHER PROBLEMS REPORTED. A MEDTRONIC REP TESTED THE RETURNED MONITOR AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. CHECKED THE BIOS REV AND FOUND THAT IT IS DOWN A REV, IT IS REV B.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED THAT THE FUSION NAVIGATION SYSTEM MONITOR WOULD INTERMITTENTLY FLICKER BLACK. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1