BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 4926089 · Received July 20, 2015

    Report

    Report Number
    1723170-2015-00894
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    June 24, 2015
    Report Date
    February 18, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT CAMERA WAS GOING IN AND OUT BUT BY THE END OF THE PROCEDURE, IT WAS SOLIDLY RED AND SYSTEM DISPLAY MESSAGE LOCALIZER DISCONNECTED. ON (B)(4) 2015 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. RETURN REQUESTED. REPLACEMENT I/O HUB ENCLOSED PCA SHIPPED TO SITE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. ON (B)(4) 2015 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, SOFTWARE AND INSTRUMENTS AREAS PASSED. HARDWARE TEST FAILED. POWER CYCLING ON CAMERA. THIS PROBLEM IS INTERMITTENT AND COULD NOT BE REPRODUCED WHILE ON-SITE. THE PROBLEM IS THE RESULT OF THE I/O HUB IN THE NAVIGATION INTERFACE UNIT (NIU). TESTED THE NIU POWER SUPPLY AND EVERYTHING CHECKED OUT. REPLACED THE I/O HUB AND TRANSCEIVER IN THE NIU. ISSUE WAS RESOLVED. SYSTEM PERFORMED AS INTENDED. THE SITE HAS USED THE SYSTEM FOR 3 CASES SINCE THE REPAIR WITHOUT PROBLEM. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015.STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿

    Additional Manufacturer Narrative · 1

    THE I/O HUB WAS NOT RETURNED IN THE MANUFACTURING PACKAGING BUT WAS PACKED WELL TO PROTECT THE PART. ONE OF THE CORNERS HAD BEEN BENT, IT APPEARS THAT THE PART WAS DROPPED. PERFORMED A FUNCTIONAL TEST OF THE PART AND NO ISSUES WERE OBSERVED. RAN THE COMPONENT FOR 24 HOURS AND NO CAMERA ISSUES WERE OBSERVED. THE PART WAS FULLY FUNCTIONAL.THE SOFTWARE INVESTIGATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE BEHAVIOR CANNOT BE REPLICATED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE NAVIGATION SYSTEM CAMERA WAS CYCLING WITHIN THE NAVIGATION SCREEN. APPROXIMATELY EVERY THREE MINUTES, THE CAMERA WOULD LOSE TRACKING ABILITY FOR ABOUT 15 SECONDS BEFORE RE-GAINING FUNCTIONALITY, 3 BEEPS. THE MEDTRONIC REPRESENTATIVE RE-STARTED THE SOFTWARE, HOWEVER, THE ISSUE WAS NOT RESOLVED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468805 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR