BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 8411660 · Received March 12, 2019

    Report

    Report Number
    1723170-2019-01057
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 12, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE POSITIONING SENSOR UNIT (PSU) OF THE NAVIGATION SYSTEM WAS REPLACED. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. (B)(4). THE POSITIONING SENSOR UNIT (PSU) WAS RETURNED TO THE MANUFACTURER AND ANALYZED VIA FUNCTIONAL TESTING, VISUAL/PHYSICAL EXAMINATION, AND PROCEDURALIZED DEVICE TESTING. THE RESULTS CONFIRMED THE REPORTED ISSUE AS THERE WAS AN ELECTRICAL FAULT; THE ILLUMINATOR CURRENT WAS OUT OF RANGE. THE AMBER FAULT LIGHT CAME ON SHORTLY AFTER POWER UP. A CHECK OF THE EVENT LOG REVEALED NUMEROUS LOW ILLUMINATOR CURRENT ERRORS. OTHERWISE, THE PSU PASSED AN ACCURACY TEST (AAK) AT .29 MM WITH A PASSING THRESHOLD OF .35 MM. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. EVALUATION CODES 10, 120, 4307 APPLY TO THIS TESTING. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733437, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR MULTI LEVEL SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT BEFORE A CASE SETUP THAT THE AMBER FAULT LIGHT WAS LIT ON THE POSITIONING SENSOR UNIT (PSU). THE SYSTEM WAS INDICATED AS PERFORMING WITHOUT ISSUES IN THE CASE BEFORE. THE PSU WAS FULLY FUNCTIONAL DURING THE PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. THE CLINICAL SPECIALIST (CS) REPORTED THAT DURING TROUBLESHOOTING HE CHECKED THE NDI LOGS AFTER THE CASE COMPLETED AND FOUND A FAULT IN THE DIAGNOSTIC LOGS STATING "ILLUMINATOR FAULT" IN THE NDI DIAGNOSTICS. PROCEEDED TO REPLACE PSU UNDER WARRANTY AS PRIOR REPLACEMENT WAS DONE UNDER A PREVIOUS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204748 STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR