BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3923566 · Received July 9, 2014

    Report

    Report Number
    1723170-2014-00738
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE STATEMENT FROM THE SURGEON, IT WAS DEEMED THE INACCURACY WAS DUE TO MOVEMENT OF THE CRANIAL REFERENCE FRAME DURING SURGERY AND NOT A MALFUNCTION OF A MEDTRONIC DEVICE. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A TUMOR RESECTION PROCEDURE, THE SURGEON NOTED THAT THE CRANIAL REFERENCE FRAME MOVED AFTER GOING STERILE AND A 1CM INACCURACY WAS NOTED. NAVIGATION WAS ONLY NEEDED FOR TURNING THE BONE FLAP, THEREFORE, THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400365 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR