BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19061919 · Received April 8, 2024

    Report

    Report Number
    1723170-2024-01024
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 2, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD AND THE CAMERA WAS REPLACED AND THE SYSTEM THEN PERFORMED AS INTENDED. CODES B01, C07, C08, AND D02 ARE APPLICABLE TO THIS SYSTEM SERVICING. H3, H6) THE PRODUCT ID: 9735821, LOT NUMBER: P901046, WAS RETURNED TO THE MANUFACTURER AND ANALYSIS CONFIRMED THE REPORTED EVENT. THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD MANY NICKS AND SCRATCHES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO SEPTEMBER OF 2018 AND INTERMITTENT ILLUMINATOR CURRENT LOW DATING BACK TO DECEMBER OF 2021. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .745 MILLIMETERS (MM) WITH A PASSING THRESHOLD OF .250MM. CODES B01, C07, C08, AND D02 ARE APPLICABLE TO THIS SYSTEM SERVICING. 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: NO HARDWARE PARTS HAVE BEEN RETURNED FOR ANALYSIS. B17, C20, D15 ARE APPLICABLE. H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A05 WAS CODED FOR THE AMBER LIGHT ILLUMINATED ON THE CAMERA, AND THE BUMP STATUS AND INTERNAL TEMPERATURE WARNING IN THE NDI. A1102 WAS CODED FOR THE LOCALIZER FAULTED 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.

    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 WAS ILLUMINATED ON THE CAMERA AND THAT THE SYSTEM WAS DISPLAYING A LOCALIZER FAULTED MESSAGE. THE MANUFACTURER REPRESENTATIVE LOGGED INTO NETWORK DEVICE INTERFACE (NDI) TOOL BOX, AND BUMP STATUS AND INTERNAL TEMPERATURE WARNINGS WERE TRIGGERED. THE MOST LIKELY / SUSPECTED CAUSE OF THE ISSUE WAS THE CAMERA BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428722 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown