BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19259428 · Received May 7, 2024

    Report

    Report Number
    1723170-2024-01211
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 30, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME ; PRODUCT ID (B)(4) (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. CODES B17, C20, D15 ARE APPLICABLE. H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A1102 WAS CODED FOR THE LOCALIZER FAULTED MESSAGE. A05 WAS CODED FOR THE AMBER LIGHT. 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

    H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD AND HARDWARE PARTS WERE REPLACED. ADDITIONAL INFORMATION WAS NOT PROVIDED. PREVIOUSLY REPORTED CODE, D15 IS APPLICABLE AS WELL AS NEWLY REPORTED CODES B01 AND C19. H3, H6) THE PRODUCT ID: 9733437R, LOT NUMBER: P900873, WAS RETURNED AND ANALYSIS CONFIRMED THE REPORTED EVENT. THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT ILLUMINATOR CURRENT LOW DATING BACK TO JULY OF 2018 AND INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO OCTOBER OF 2018. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU ALSO FAILED AN ACCURACY TEST (AAK) AT .877 MILLIMETERS (MM) WITH A PASSING THRESHOLD OF .250MM. CODES B01, C07, C08, C02, AND D02. 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 AMBER LIGHT ON THE CAMERA WAS ILLUMINATED AND THE APPLICATION WAS PROMPTING A "LOCALIZER FAULTED" MESSAGE. NO PATIENT WAS PRESENT. TROUBLESHOOTING INFORMATION WAS PROVIDED. TECHNICAL SERVICES (TS) HAD THE MEDTRONIC REPRESENTATIVE (REP) OPEN THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX AND FOUND THREE STATUS MESSAGES: BUMP DETECTOR BATTERY FAULT, BUMP DETECTED, AND STORAGE TEMPERATURE EXCEEDED. TS ALSO HAD THE REP CHECK CAMERA EVENT LOGS AND STATUS MESSAGES PROMPTED AT SAME TIME. THE PROBABLE CAUSE WAS SUSPECTED TO BE AN ERRONEOUS BUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400841 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...