BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAYPOINT STEREOTACTIC SYSTEM

    MDR report key: 4121854 · Received July 31, 2014

    Report

    Report Number
    3005677147-2014-00005
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 25, 2014
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED PLATFORM, PRE-OP PLANS AND POST-OP IMAGES SUGGESTS THAT THE LEAD WAS IMPLANTED ALONG THE INTENDED TARGET BUT WAS AT THE INCORRECT DEPTH AND MAY HAVE SLIPPED AT SOME POINT DURING IMPLANTATION. NO ISSUES WERE FOUND WITH THE PLATFORM OR OTHER EQUIPMENT USED IN THE CASE. NO ADVERSE EFFECTS WERE NOTED WITH THE PATIENT, HOWEVER, THE PATIENT WAS RESCHEDULED FOR SURGERY TO REVISE THE PLACEMENT OF THE LEAD. REVISION WAS SUCCESSFULLY PERFORMED ON (B)(6) 2014 WITH NO ISSUES. ON (B)(6) 2014 - FHC REPRESENTATIVE ATTENDED REVISION AND DISCUSSED THE EVENT WITH THE PHYSICIAN. NO DEFINITIVE CAUSE OF THE INCORRECT DEPTH OF THE LEAD COULD BE DETERMINED. HOWEVER, THE SCRUB NURSE THAT USUALLY MEASURES THE LEAD WITH THE FHC MEASUREMENT TOOLS WAS ON VACATION DURING THE EVENT. FHC REPRESENTATIVE REVIEWED THE LEAD MEASUREMENT STEPS WITH THE STAFF.

    Description of Event or Problem · 1

    DR (B)(6) REPORTED THAT DURING A DBS PROCEDURE - LEFT STN, THE LEAD WAS IMPLANTED OFF THE INTENDED TARGET. FHC EQUIPMENT USED WAS WAYPOINT PLATFORM, MT CONTROLLER AND STARDRIVE. MISPLACED LEADS WERE IDENTIFIED DURING POSTOP CT AS BEING APPROXIMATELY 30MM INFERIOR TO INTENDED TARGET. PRIOR TO CT, THEY DID NOT SUSPECT ANY ISSUES. NO ADVERSE EFFECTS ON THE PATIENT HOWEVER THE PATIENT WAS RESCHEDULED FOR SURGERY TO REVISE THE PLACEMENT OF THE LEAD. REVISION WAS SUCCESSFULLY PERFORMED ON (B)(6) 2014 WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449133 WAYPOINT STEREOTACTIC SYSTEM STEREOTACTIC SYSTEM GZL FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention