BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19861545 · Received July 30, 2024

    Report

    Report Number
    1723170-2024-01862
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 30, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THREE CABLES AND ONE CONNECTOR THAT WERE RETURNED ALL PASSED CONTINUITY TESTS AND ALL WERE IN GOOD COSMETIC CONDITION, WITH NO APPARENT DAMAGE. CODES B01, C19 AND D14 ARE APPLICABLE TO THIS ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ; PRODUCT ID 9735843 (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM H3: THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, HARDWARE PARTS WERE REPLACED. CODES B01, C13, D02 ARE APPLICABLE TO THIS ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING "LOCALIZER NOT CONNECTED". MULTIPLE REBOOTS DID NOT RESOLVE THE ISSUE. NO PATIENT PRESENT. TROUBLESHOOTING INFORMATION WAS PROVIDED. THE VIDEO WAS DISPLAYED ON BOTH MONITORS. BOTH THE GREEN AND AMBER LIGHTS ON THE CAMERA WERE ILLUMINATED. DURING THE SELF-TEST, ALL INTERNAL NETWORK COMPONENTS SHOWED GREEN AND CONNECTED, EXCEPT FOR THE POSITIONING SENSOR UNIT (PSU), WHICH WAS MARKED AS "UNAVAILABLE" IN RED. IN THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX, NOTHING WAS INITIALLY DISPLAYED. THE MEDTRONIC REPRESENTATIVE (REP) SELECTED "FILE" AND "CONNECT TO," AND HAD THE OPTION OF CONNECTING TO THE SYSTEM CONTROL UNIT (SCU) BUT NOT THE PSU. UPON CONNECTING TO THE SCU IN NDITOOLBOX, NO FAULT STATUSES WERE FOUND. THE POE INJECTOR LIGHT WAS GREEN. THE REPRESENTATIVE THEN BYPASSED THE INTERNAL ETHERNET CABLING CHAIN WITH A KNOWN WORKING ETHERNET CABLE, WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282076 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11