BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21001744 · Received December 23, 2024

    Report

    Report Number
    1723170-2024-04018
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 5, 2024
    Report Date
    January 10, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. H3, H6: A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE LOCALIZER FAULTED MESSAGE WAS DUE TO A CAMERA BATTERY FAILURE. THE BROKEN CAMERA WAS REPLACED. CODES B01, C08, AND D02 ARE APPLICABLE. MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A05 WAS CODED FOR THE LOCALIZER FAULTING. 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

    H3: ANALYSIS WAS PERFORMED FOR PRODUCT 9735821, LOT NUMBER: P902685. IT WAS REPORTED THAT THE RETURNED POWER SUPPLY UNIT (PSU) HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO JAN 2020. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .430MM WITH A PASSING THRESHOLD OF .250MM. PREVIOUSLY CODED B01, C08 AND D02 ARE STILL 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 DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT DURING AN OPTICAL CRANIAL TUMOR RESECTION CASE, THE SYSTEM GAVE A "LOCALIZER FAULTED" ERROR MESSAGE. THE ISSUE OCCURRED AS THE SURGEON WAS ABOUT TO PERFORM REGISTRATION. THE SITE WAS ABLE TO RE-PIN THE PATIENT USING A NON-METALLIC FRAME AND SWITCHED TO ELECTROMAGNETIC (EM). THE PROBABLE CAUSE WAS THE CAMERA, EITHER DUE TO A TRUE BUMP OR ERRONEOUS BUMP. THERE WAS A LESS THAN ONE HOUR DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626140 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female