BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2052546 · Received April 8, 2011

    Report

    Report Number
    1723170-2011-00764
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT COULD NOT BE OBTAINED FROM THE SITE. A SOFTWARE INVESTIGATION FOUND THAT THE SOFTWARE FUNCTIONED AS DESIGNED. THE BATTERIES IN WIRELESS TRACKER WERE COMPLETELY DRAINED. AFTER REPLACING THE BATTERY, THE ISSUE COULD NOT BE REPLICATED IN FLUOROMERGE OR FLUORONAV.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINE SURGERY, THEY WERE NOT ABLE TO SUCCESSFULLY ACTIVATE IMAGES TRANSFERRED FROM A PHILIPS BV PULSERA C-ARM TO THE STEALTHSTATION S7 SYSTEM. THE BATTERIES WERE FOUND TO BE DRAINED FROM THE WIRELESS TARGET. THE SURGERY WAS RESCHEDULED AS THERE WAS NO BACK-UP BATTERY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention