BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3844988 · Received June 3, 2014

    Report

    Report Number
    1723170-2014-00536
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT MADE AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED IT WAS A CODMAN CATHETER INTRODUCER THAT THE SURGEON WAS USING WITH THE NAVIGATION SOFTWARE AND SURETRAK. THIS ITEM SHOULD NOT BE NAVIGATED WITH A SURETRAK, AS IT HAS A HOLLOW SHAFT AND IS NOT RIGID. THIS RESULTED IN BEING INACCURATE BY 4-5MM MEDIALLY ACCORDING TO THE SURGEON. ALL OTHER INSTRUMENTS NAVIGATED WERE REPORTEDLY ACCURATE. THE MEDTRONIC REPRESENTATIVE WAS ABLE TO REPLICATE THE REPORTED ISSUE USING A DEMO MODEL. THE MEDTRONIC REPRESENTATIVE FOUND THAT USING THE CODMAN ITEM AND SURETRAK WAS NOT OPTIMAL FOR NAVIGATION ACCURACY. RECOMMENDATIONS WERE MADE TO THE SURGEON, AND THE SITE, REGARDING PROPER USE OF THE SURETRAK. SOFTWARE INVESTIGATION COMPLETED. FINDINGS ARE THAT THE SITE USED THE APPLICATION IN AN OFF-LABEL MANNER AND WERE UNSUCCESSFUL. UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY. HARDWARE INVESTIGATION COMPLETED. FINDINGS ARE THAT THE SYNERGY CRANIAL SOFTWARE ((B)(4)) IFU (PAGE 114) WARNS THE USER NOT TO USE THE SURETRAK FIGHTER WITH A FLEXIBLE INSTRUMENT. NO PARTS WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER ANALYSIS ALL NECESSARY TESTING WAS PERFORMED IN THE FIELD. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A SURGEON ALLEGED AN INACCURACY OCCURRED DURING A CRANIAL VENTRICULOPERITONEAL SHUNT PLACEMENT PROCEDURE UTILIZING THE STEALTHSTATION NAVIGATION SYSTEM. THE SURGEON WAS USING A SURETRAK TRACKER WITH A CATHETER INTRODUCER SHEATH. THE CATHETER INTRODUCER IS A FLEXIBLE INSTRUMENT AND THE INTERNAL SHAFT OF THE INTRODUCER WAS STICKING OUT APPROXIMATELY 5MM. THE SURGEON CONFIRMED THAT AFTER CALIBRATING THE CATHETER INTRODUCER, HE RECEIVED A WARNING MESSAGE IN THE NAVIGATION SOFTWARE STATING "NOT A VALID INSTRUMENT TO BE USED WITH SURETRAK." THE SURGEON DISREGARDED THE WARNING MESSAGE AND PROCEEDED TO NAVIGATE - WHILE NOTING A 4-5MM INACCURACY MEDIALLY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO HARM TO THE PATIENT REPORTED AT THE TIME OF THE PROCEDURE. THE MEDTRONIC REPRESENTATIVE WAS LATER INFORMED THAT THE FORNIX OF THE BRAIN WAS PERFORATED DURING THE PROCEDURE. THE SURGEON STATED THERE WERE NO DEFICITS NOTED DURING POSTOPERATIVE FOLLOW UP WITH THE PATIENT. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AS THE SURGEON CHOSE TO USE THE SYSTEM IN AN UNAPPROVED MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324193 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other