BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2050111 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00570
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT PRESENT. THE MEDTRONIC REP REINSTALLED THE MACH CRANIAL SOFTWARE AND RE-CALIBRATED THE MICROSCOPE WITH THE NAVIGATION SYSTEM. NO FURTHER ISSUES.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THAT DURING A DEMONSTRATION DIRECTLY FOLLOWING THE CALIBRATION OF THE NAVIGATION SYSTEM WITH A MICROSCOPE, THE MACH CRANIAL SOFTWARE CRASHED (EXITED TO LOGIN SCREEN) TWICE. THE FIRST CRASH OCCURRED WHEN HE SELECTED THE MICROSCOPE BOUNDARY AND THE SECOND OCCURRED WHEN HE SELECTED THE SCOPE IN THE PROBES LIST. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    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