BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION IMAGE GUIDED TREATMENT

    MDR report key: 521826 · Received April 22, 2004

    Report

    Report Number
    1723170-2004-00003
    Event Type
    Injury
    Date Received
    April 22, 2004
    Date of Event
    September 25, 2003
    Report Date
    April 20, 2004
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT BEGAN TO HEMORRHAGE AFTER BIOPSY PROCEDURE-PT RETURNED TO SURGERY TO EVACUATE HEMORRHAGE AND FOUND TO BE HEMIPLEGIC ON THE LEFT SIDE AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION IMAGE GUIDED TREATMENT IGS SYSTEM HAW MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 960-090 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other