BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION IMAGE GUIDED TREATMENT

    MDR report key: 521835 · Received April 22, 2004

    Report

    Report Number
    1723170-2004-00002
    Event Type
    Injury
    Date Received
    April 22, 2004
    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 WITH PARTIAL PARALYSIS UNDERWENT INITIAL BIOPSY PROCEDURE AT SITE #1 - SPECIMEN WAS NON-DIAGNOSTIC. SAME PT UNDERWENT ANOTHER BIOPSY AT SITE #2 - SURGEON COMMENTED ON INCREASED PARALYSIS SINCE INITIAL BIOPSY AT SITE #1 AND ALLEGED THAT THE BX NEEDLE WENT THROUGH THE MOTOR CORTEX AT SITE #1. STEALTHSTATION SYSTEM/ACCESSORIES/INSTRUMENTS MET INTENDED USE AND INDICATIONS REQUIREMENTS.

    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