BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3033878 · Received April 3, 2013

    Report

    Report Number
    1723170-2013-00252
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO CHARACTER LIMITATIONS THE FUL PATIENT IDENTIFIER IS: (B)(6). PATIENT SEX WAS NOT AVAILABLE FROM THE SITE.

    Additional Manufacturer Narrative · 1

    A SOFTWARE INVESTIGATION WAS COMPLETED, BUT WAS FOUND TO BE INCONCLUSIVE AS THE LOG FILES PROVIDED FROM THE SYSTEM DID NOT CONTAIN DATA THAT CONFIRMED THE REPORTED COMPLAINT AND THE ISSUE HAS NOT RECURRED. UNABLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A BIOPSY CASE THE SCREEN FROZE ON LOADING BEFORE GOING TO REGISTRATION SCREEN ON THE S7. THEY ATTEMPTED TO LOAD DIFFERENT PATIENTS AND AGAIN THE SYSTEM FROZE WHEN THEY TRIED TO MOVE TO THE REGISTRATION SCREEN. THEY HAD TO DO A HARD SHUT DOWN OF THE SYSTEM BECAUSE THEY WERE UNABLE TO EXIT, OR PERFORM A SOFT RESTART OR SHUTDOWN THE SOFTWARE. HOWEVER, THE SYSTEM WORKS PROPERLY WHEN USING THE SPINE PROCEDURE. THE SITE USED ANOTHER S7 TO COMPLETE THE CASE AS PLANNED. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136672 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR