BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREATMENT GUIDANCE PLATFORM

    MDR report key: 298611 · Received October 3, 2000

    Report

    Report Number
    1723170-2000-00003
    Event Type
    Injury
    Date Received
    October 3, 2000
    Date of Event
    September 1, 1999
    Report Date
    October 2, 2000
    Manufacturer
    MEDTRONIC SURGICAL NAV. TECH.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES WAS SERVED WITH A LEGAL COMPLAINT ON 9/7/2000. IT IS ALLEGED IN 1999, THE DEVICE WAS USED AND CONTRIBUTED TO A PERMANENT INJURY OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREATMENT GUIDANCE PLATFORM IMAGE GUIDED STEREOTACTIC DEVICE HAW MEDTRONIC SURGICAL NAV. TECH. STEALTHSTATION SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability