BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    MDR report key: 2113725 · Received June 2, 2011

    Report

    Report Number
    1723170-2011-01047
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE WAS DISPOSABLE AND THERE IS NO MANUFACTURE DATE INFORMATION AT THE TIME OF THIS REPORT. THE DEVICE WAS A DISPOSABLE DEVICE AND WAS NOT RETURNED FOR EVALUATION. SOFTWARE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A NAVIGUS BIOPSY CASE, THE SURGEON TOOK A BIOPSY OF HEALTHY TISSUE WHICH LEAD TO A HEMORRHAGE OF THE PATIENT. THE SURGERY WAS THEN RE-SCHEDULED FOR MAY 5TH, AND THE FOLLOW-UP CASE WENT AS PLANNED WITH NO REPORTED ISSUES. THEY WERE USING SYNERGY CRANIAL IN ONE OF THEIR I7 ROOMS. THE MEDTRONIC REPRESENTATIVE NOTED THAT THE SURGEON WAS USING THE EXTERNAL ANGLED NAVIGUS BASE, BUT SAID THAT HE ATTEMPTED TO "SHIM" THE BASE BY USING A TONGUE RETRACTOR UNDERNEATH IT TO PROVIDE MORE ANGLE. THE MEDTRONIC REPRESENTATIVE WAS UNCLEAR HOW, OR IF, THE SURGEON SECURED THE BASE TO THE PATIENT'S SKULL, AS THE SCREWS PROVIDED WOULD NOT BE SUFFICIENT WITH A SHIM ADDED UNDERNEATH. SURGERY WAS RESCHEDULED. SURGERY WENT AS PLANNED FOR RESCHEDULED CASE AND THERE WERE NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention