BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4932536 · Received July 22, 2015

    Report

    Report Number
    1723170-2015-00905
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 25, 2015
    Report Date
    February 23, 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

    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

    DEVICE MANUFACTURING DATE NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    TROUBLE-SHOOTING IMMEDIATELY FOLLOWING THE PROCEDURE RESOLVED THE ISSUE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, AFTER THE SCREWS WERE PLACED, THE NAVIGATION SYSTEM CAMERA WENT TO LOCALIZER NOT CONNECTED AND WAS DISPLAYING A RED X; AT THIS TIME THE SPINE SOFTWARE BECAME UNRESPONSIVE. THE SURGEON PROCEEDED USING THE 3D SPIN TO CONFIRM SCREW PLACEMENT. THERE WAS NO DELAY IN THE SURGERY. ALL SCREWS WERE SUCCESSFULLY PLACED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. IN TROUBLE-SHOOTING, FOLLOWING THE PROCEDURE, IT WAS DISCOVERED THAT THE POWER CABLE TO THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) BOX HAD BECOME LOOSE. RE-SEATED THE POWER CABLE TO THE SCU, IN THE UPS, AND THE CAMERA AND NAVIGATION SYSTEM NORMAL FUNCTION WAS RESTORED. THERE WERE NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476123 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR