BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2760897 · Received September 26, 2012

    Report

    Report Number
    1723170-2012-00546
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ERROR LOGS HAVE BEEN REQUESTED. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    MEDTRONIC REPRESENTATIVE COULD NOT REPLICATE THE ISSUE. SYSTEM PERFORMED PROPERLY. SOFTWARE INVESTIGATION WAS COMPLETED THE LOG FILE IS CORRUPTED. SOME OF LOG FILE FOR DAY OF COMPLAINT IS STILL INTACT. THERE WAS A PROBLEM OPENING A DIRECTORY, AS INDICATED BY THE ARGUSSTORAGEMANAGEMENT/POSTPROC_INVOCATION MESSAGE, "ERROR OPENING DIR" FOR A LOG FILE, WHICH CONTAINED AN AXIEM "ERROR: AMPLIFIER POWER FAULT" MESSAGE.. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL TUMOR RESECTION PROCEDURE, THE SURGEON ALLEGED THE SOFTWARE WAS UNRESPONSIVE. A MEDTRONIC REPRESENTATIVE WALKED THROUGH TROUBLE-SHOOTING; THEN SITE PERFORMED A HARD RE-BOOT, RE-ENTERED THE APPLICATION AND CONTINUED WITH NAVIGATION. THERE WERE NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT ON THE PATIENT OUTCOME REPORTED.

    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 70 YR