BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2881943 · Received December 20, 2012

    Report

    Report Number
    1723170-2012-00761
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT UNAVAILABLE FROM THE SITE. FOLLOW-UP FINDINGS CONFIRM HEALTHY TISSUE WAS REMOVED FROM THE PATIENT. SYSTEM CHECK-OUT PERFORMED, RESULTS ARE NO ISSUES FOUND. SINCE THIS EVENT, REPORT IS THAT THE SYSTEM IS FUNCTIONING NORMALLY, NO FURTHER ISSUES REPORTED. SOFTWARE INVESTIGATION SO FAR INDICATES USER PERFORMED INADEQUATE TRACER REGISTRATION OF HEAD. SOFTWARE EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE ENGINEERS REVIEWED THE TRACING PATTERN ARCHIVE OF THIS PATIENT EXAM. THE PATIENT'S EXAM EXHIBITS DEPRESSIONS IN THE SKIN ON SOME AREAS THAT THE TRACER PATTERN WAS PERFORMED ON. THE TRACING PATTERN IS SUBOPTIMAL. UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, BIOMED, REPORTED AN ALLEGED 2CM INACCURACY WHILE IN A CRANIAL SURGERY, A POSTERIOR TUMOR RESECTION. THE Z-AXIS (DEPTH) WAS SPOT-ON AND THE X/Y AXIS WAS REPORTED TO BE OFF, HOWEVER, THERE WERE NO PROBLEMS WITH REGISTRATION. THE SURGEON PROCEEDED WITH THE PROCEDURE AND REMOVED THE TUMOR (TUMOR RESECTION). THE PATIENT WAS RE-SCANNED AND THE TUMOR WAS STILL IN THE BRAIN, AT THIS POINT IS WHEN THE SURGEON ALLEGED THE INACCURACY. PATIENT WAS RE-SCANNED CT AND WILL BE RE-SCHEDULED FOR SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization