BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19510759 · Received June 11, 2024

    Report

    Report Number
    1723170-2024-01457
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 20, 2024
    Report Date
    July 9, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: 9735771, LOT NUMBER: UNKNOWN PRODUCT ID: 9735788, LOT NUMBER: UNKNOWN PRODUCT ID: 9735815, LOT NUMBER: UNKNOWN PRODUCT ID: 9735996, LOT NUMBER: UNKNOWN H6: A0902 - CODED FOR DISPLAY ISSUES (BLACK SCREEN) A0708 - CODED FOR POWER ISSUE (NOT ABLE TO DETERMINE IF THE CAMERA CART HAD POWER OR NOT) ADDITIONAL CODES: G02002 - CODED FOR BATTEY (PRODUCT 9735771) G02004 - CODED FOR CABLE (9735815 AND 9735996) G02027 - CODED FOR POWER SUPPLY (9735788) 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 - EVALUATION OF THE RETURNED BATTERY 9735771 LOT# 1819 CONFIRMED THE EVENT. DURING THE 24 HOUR TEST THE UPS SHUT DOWN DUE TO THE BATTERY OVERHEATING THUS CAUSING NO POWER. CODES B01, C02, D02 APPLY. EVALUATION OF THE RETURNED POWER SUPPLY 9735788 LOT# 1820272 AND CABLE 9735815 LOT# 170928 FOUND NO FAULT WITH THE RETURNED COMPONENTS. CODES B01, C19, D14 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 AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE CAMERA CART DISPLAYED A BLACK SCREEN. THEY WERE NOT ABLE TO DETERMINE IF THE CAMERA CART HAD POWER OR NOT. THEY SWITCHED TO ANOTHER SYSTEM TO CONTINUE SURGERY. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295040 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female "SEE H11...."