BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19874283 · Received July 31, 2024

    Report

    Report Number
    1723170-2024-01889
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 17, 2024
    Report Date
    September 18, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6 - A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO SERVICE THE SYSTEM. HARDWARE COMPONENTS WERE REPLACED. CODES B01, C02, D02 APPLY. EVALUATION OF THE RETURNED POWER SUPPLY 9735788 LOT# 18160531 AND 9735787 LOT# 2140037 FOUND NO FAULT WITH THE COMPONENTS. CODES B01, C19, D14 APPLY. EVALUATION OF THE RETURNED BATTERY 9735771 LOT# 1814 AND 9735773 LOT# 2024 FOUND LOW VOLTAGE AND DEAD CELLS. CODES B01, C02, 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.

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ; PRODUCT ID 9735771 (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM BRAND NAME ; PRODUCT ID 9735788 (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM BRAND NAME ; PRODUCT ID 9735773 (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM BRAND NAME ; PRODUCT ID 9735787 (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. 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 WHEN THE MEDTRONIC REPRESENTATIVE (REP) BOOTED UP THE SYSTEM THERE WAS A BATTERY SERVICE ERROR. NO PATIENT WAS PRESENT. TROUBLESHOOTING INFORMATION WAS PROVIDED. TECHNICAL SERVICES (TS) HAD REP GO INTO SELF-TEST AND BOTH THE MAIN AND CAMERA CART BATTERY PERCENTAGE WERE 0%. THEY UNPLUGGED THE SYSTEM FROM WALL POWER AND BOTH THE MAIN AND CAMERA CART POWERED OFF IMMEDIATELY. THE PROBABLE CAUSE SUSPECTED TO BE BOTH THE MAIN AND CAMERA CART'S UPS AND BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215783 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

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