BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREATMENT GUIDANCE PLATFORM

    MDR report key: 332953 · Received May 14, 2001

    Report

    Report Number
    1723170-2001-00001
    Event Type
    Malfunction
    Date Received
    May 14, 2001
    Date of Event
    January 1, 2000
    Report Date
    May 14, 2001
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2000 A PT UNDERWENT A CRANIAL PROCEDURE AND WAS LATER DIAGNOSED WITH CREUTZFELDT-JAKOB DISEASE (CJD). THE PT WAS DIAGNOSED AS HAVING THE DISEASE ON 12/2000. IT WAS REPORTED TO MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES AFTER 12/2000 THAT THE STEALTHSTATION INSTRUMENTATION WAS UTILIZED FOR A PORTION OF THE PROCEDURE CONDUCTED IN 2000. BASED ON THE INVESTIGATION WHICH HAS REVEALED LIMITED INFO, IT IS SUSPECTED THAT WITHIN 22 DAYS, SIX SUBSEQUENT PTS MAY HAVE BEEN EXPOSED TO INSTRUMENTATION WHICH WAS UTILIZED IN THE 2000 PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22646 STEALTHSTATION TREATMENT GUIDANCE PLATFORM IMAGE GUIDED STEREOTACTIC DEVICE HAW MEDTRONIC SURGICAL NAVIGATION STEALTHSTATION SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN