BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20902515 · Received December 11, 2024

    Report

    Report Number
    1723170-2024-03848
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    December 2, 2024
    Report Date
    January 29, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 735821, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A05 WAS CODED FOR ERRONEOUS DETECTED BUMP FAILURE ON THE CAMERA. A1102 WAS CODED FOR THE ERROR MESSAGE. 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

    D9, H2, H3: THE RETURN OF 9735821 PROVIDED THE LOT NUMBER P901231. THE HARDWARE WAS RETURNED AND ANALYSIS WAS PERFORMED. THE RETURNED POSITIONING SENSOR UNIT (PSU) CONTAINS SCRATCHES ON THE HOUSING LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO NOVEMBER 2018 AND A SENSOR TEMP NOT FUNCTIONING ERROR DATING BACK TO MAY 2019. THERE WAS ALSO A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .543MM WITH A PASSING THRESHOLD OF .250MM. CODES FDM B01, FDR C02, FDC 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.

    Additional Manufacturer Narrative · 0

    A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THE SYSTEM UNDERWENT A COMPREHENSIVE EVALUATION, INCLUDING HARDWARE, SOFTWARE, INSTRUMENTS, VISUAL INSPECTION, AND A SELF-TEST. HARDWARE PARTS WERE REPLACED, ALTHOUGH THE WORK ORDER DID NOT SPECIFY WHICH PARTS WERE REPLACED. AFTER COMPLETION, IT WAS CONFIRMED THAT THE SYSTEM PERFORMED AS INTENDED. CODES B01, C13, D02 APPLY. 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 THERE WAS AN ERRONEOUS DETECTED BUMP FAILURE ON A CAMERA. THE ISSUE WAS IDENTIFIED WHEN A BUMP MESSAGE APPEARED ON THE CAMERA. DURING TROUBLESHOOTING, TECHNICAL SERVICES RECEIVED A PICTURE CONFIRMING THE ERRONEOUS DETECTED BUMP FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2443383 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

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