BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3582453 · Received January 17, 2014

    Report

    Report Number
    1723170-2014-00061
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Date of Event
    June 20, 2013
    Report Date
    July 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT SYSTEM CONTROL UNIT (SCU) SHIPPED TO SITE (B)(4) 2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT SYSTEM CONTROL UNIT (SCU) FINDS THAT, DURING A FUNCTIONAL TEST THE SCU SEEMED TO FUNCTION NORMALLY BUT SUDDENLY WENT TO BLACK STATUS BRIEFLY, NOT COMMUNICATING WITH THE POSITIONING SENSOR UNIT (PSU), THEN RETURNED TO NORMAL TRACKING. EVENT LOGS INDICATED A HISTORY OF INCIDENTS WHERE THE SCU HAD DIFFICULTY ESTABLISHING COMMUNICATION WITH PORT 1. MORE RECENTLY THE SCU WAS REPORTING AN INTERMITTENT INTERNAL STROBE ERROR. ELECTRICAL FAILURE, COMMUNICATION ERROR, DIRECTLY CAUSED THE EVENT. ON (B)(4) 2013, A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM CONTROL UNIT (SCU) WORKING AS IT SHOULD.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE NAVIGATION SYSTEM CONTROL UNIT (SCU) WAS WORKING INTERMITTENTLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44920 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1