BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 17904276 · Received October 10, 2023

    Report

    Report Number
    1723170-2023-01913
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    October 5, 2023
    Report Date
    May 9, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169876972
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6: THE CAMERA, LOT NUMBER P901063, WAS RETURNED AND ANALYZED. THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY AND INTERMITTENT ILLUMINATOR CURRENT LOW. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST. CODES B01, C02, AND 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. 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: PRODUCT ID: 9735821, LOT/SERIAL #: UNKNOWN H3) THE MANUFACTURE REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. THEY REPLACED THE CAMERA. NO CALIBRATED INSTRUMENTS WERE USED IN THIS CHECKOUT/REPAIR. SYSTEM FULLY FUNCTIONAL AND READY FOR CLINICAL USE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 A LOCALIZER FAULTED. WHILE PERFORMING A PLANNED MAINTENANCE, THE AMBER LIGHT ON THE CAMERA WAS ILLUMINATED. THE MANUFACTURER REPRESENTATIVE (REP) OPENED THE NDITOOLBOX AND NOTICED THAT THE BUMP AND STORAGE TEMPERATURE FAULT STATUSES WERE TRIGGERED. THE REP LOGGED INTO THE CLINICAL APPLICATION AND REPORTED THAT INSTRUMENTS COULD BE TRACKED USING THE CAMERA, BUT THE MESSAGE "LOCALIZER FAULTED" WAS DISPLAYED. TROUBLESHOOTING WAS PERFORMED AND A REBOOT DID NOT RESOLVE THE ISSUE, CONFIRMED AMBER LIGHT WAS STILL ILLUMINATED AND "LOCALIZER FAULTED" WAS DISPLAYED. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THAT THIS WAS A CAMERA ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283132 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735667 00643169876972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10...