BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4731465 · Received April 27, 2015

    Report

    Report Number
    1723170-2015-00507
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Date of Event
    March 30, 2015
    Report Date
    February 18, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE HARDWARE ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. ADDITIONAL INFORMATION: THE SYSTEM CONTROL UNIT (SCU) WAS SENT TO THE VENDOR FOR ADDITIONAL ANALYSIS WHICH CONFIRMED THE PREVIOUSLY REPORTED FINDINGS. THE SCU WOULD NOT COMMUNICATE OR SUPPLY POWER TO THE POSITIONING SENSOR UNIT (PSU) DUE TO A FAULTY COMPONENT ON THE MAIN BOARD BEING INTERNALLY SHORTED. AS A RESULT THE EFFECTED COMPONENT WAS REPLACED FOLLOWED BY APPLICABLE TESTING TO ENSURE PROPER OPERATION.

    Additional Manufacturer Narrative · 1

    THE SUSPECT PSU (POSITION SENSOR UNIT A.K.A. CAMERA) AND SCU (SYSTEM CONTROL UNIT) WERE RETURNED FOR ANALYSIS. RESULTS AS FOLLOWS: PSU: MANUFACTURE DATE OCT 2014. AS RECEIVED, FIRMWARE REV 14. WHEN CONNECTED TO A KNOWN GOOD SYSTEM THE PSU PERFORMED AS EXPECTED. THE PSU PASSED THE ACCURACY ASSESSMENT TESTING. NO PROBLEM FOUND. UNABLE TO DUPLICATE EVENT. SCU: MANUFACTURE DATE JUNE 2011. AS RECEIVED, FIRMWARE REV 12. WHEN CONNECTED TO A KNOWN GOOD PSU THE SCU FUNCTIONED NORMALLY AT POWER UP, BUT SOON WOULD NOT COMMUNICATE OR SUPPLY POWER TO THE PSU, ALTHOUGH THE SCU REMAINED POWERED. THE EVENT LOG HAD NOT RECORDED ANY ADVERSE EVENTS. ELECTRICAL ISSUE CAUSED EVENT.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RETURN REQUESTED. REPLACEMENT SCU KIT AND PSU KIT WERE SHIPPED TO SITE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, SOFTWARE AND INSTRUMENTS AREAS PASSED. HARDWARE TESTING FOUND THE PSU WAS NOT RECEIVING POWER SUPPLY, SCU POWER CONNECTION FAILURE. POSITIONING SENSOR UNIT (PSU) WAS NOT REPLACED, IT WAS RETURNED, UNUSED TO MANUFACTURER. POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS REPLACED. ISSUE RESOLVED. SYSTEM PERFORMED AS INTENDED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A SITE PHYSICIAN REPORTED A NAVIGATION SYSTEM THAT WAS INCAPABLE OF TRACKING INSTRUMENTS. THE POSITIONING SENSOR UNIT (PSU) DID NOT RECEIVE ANY POWER SUPPLY, THE LEDS WERE OFF. IN TROUBLE-SHOOTING, THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS POWERED DOWN. WHEN TOUCHING THE SCU'S POWER CABLE, IT TURNED ON, SUGGESTING A DISCONNECTION CAUSING THE ISSUE OR AN INTERMITTENT SCU POWER CONNECTOR. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275772 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1