BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3790309 · Received May 5, 2014

    Report

    Report Number
    1723170-2014-00446
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. SOFTWARE INVESTIGATION NOT COMPLETED - NO PARTS/FILES HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE COMPUTER BOOTED NORMALLY ON THE FIRST TIME AND POWERED UP. THE REPORTED EVENT WAS CONFIRMED THAT THE VIDEO CAPTURE CARD WAS SET TO THE INCORRECT VIDEO SIGNAL. THE VIDEO CARD WAS REPROGRAMMED AND THE PHASE ALTERNATING LINE (PAL) SIGNAL WAS VERIFIED TO BE PROCESSING ON VIDEO CAPTURE CARD. THERE WERE NO ERRORS FOUND ON THE RAM OR HARD DRIVE.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SYSTEM WAS FUNCTIONING NORMALLY AFTER COMPUTER REPLACEMENT. THE SOFTWARE INVESTIGATION FOUND THAT THE SOFTWARE FUNCTIONED AS DESIGNED. PER FURTHER REVIEW OF THE VIDEO CARD ISSUE, THE CAUSE WAS CONFIRMED TO BE HARDWARE RELATED TO VIDEO CARD AND DRIVER COMPATIBILITY WITH PHASE ALTERNATING LINE (PAL) VIDEO SIGNAL.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE ISSUE CAUSED A DELAY TO THE SURGERY OF APPROXIMATELY ONE HOUR. THE PULSERA IMAGE INTENSIFIER WAS USED TO CHECK SCREW TRAJECTORY T10-PELVIS. THERE WAS ONE MEDIAL WALL BREACH THAT WAS CORRECTED BY THE SURGEON. A REVIEW OF THE REPORTED EVENT FOUND THAT THE ISSUE WAS RELATED TO A MALFUNCTION WITH THE VIDEO CAPTURE CARD OF THE COMPUTER. THE VIDEO CARD WOULD NOT ACCEPT A PAL VIDEO SIGNAL. A REPLACEMENT COMPUTER WAS SENT TO NEW ZEALAND TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING SET-UP FOR A COMPLEX MULTI-LEVEL SPINAL FUSION, THE NAVIGATION SYSTEM WAS CONNECTED TO A PHILLIPS BV PULSERA IMAGE INTENSIFIER. THE CONNECTION INDICATOR SHOWED INTERMITTENT CONNECTION. TROUBLE-SHOOTING SEVERAL CABLES DID NOT RESOLVE THE ISSUE, THE FAULT PERSISTED. THE DECISION WAS MADE TO ATTEMPT THE IMAGE ACQUISITION WITH THE THOUGHT THAT THE IMAGES WOULD TRANSFER DURING THE INTERMITTENT PERIODS OF GREEN STATUS. THE IMAGES WERE TRANSFERRED, HOWEVER, WERE NOT USABLE DUE TO EXCESSIVE DISTORTION. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266458 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention