BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19011597 · Received April 1, 2024

    Report

    Report Number
    1723170-2024-00958
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 3, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME ; PRODUCT ID 9735821R (LOT: -); PRODUCT TYPE: 2543-MNAV - SYSTEM H3: THE SYSTEM WAS SERVICED IN THE FIELD, AND THE CAMERA WAS REPLACED. CODES B01, C08, D02 ARE APPLICABLE. H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A1102 WAS CODED FOR THE LOCALIZER FAULT MESSAGE. A05 WAS CODED FOR THE AMBER LIGHT. 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 - THE CAMERA 9735821 LOT# P900412 WAS RETURNED FOR EVALUATION. THE RETURNED CAMERA HAS MANY SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO FEB 2018 AND INTERMITTENT ILLUMINATOR CURRENT LOW DATING BACK TO MAR 2018. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE CAMERA FAILED AN ACCURACY TEST (AAK) AT .305MM WITH A PASSING THRESHOLD OF .250MM. EVALUATION 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 B5: UPDATED 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER SHOWED FAULTED WITH AN AMBER LIGHT. THE MEDTRONIC REPRESENTATIVE (REP) SAID THAT THEY WERE GOING TO USE THE CAMERA OFF OF ANOTHER SYSTEM, TO RESUME THE CASE. TECHNICAL SERVICES (TS) TOLD HIM THAT THEY COULD SWAP CAMERA CARTS, BUT THE REP SAID THAT THE CAMERA CART WAS AT A LOCATION WHERE THEY COULDN'T WHEEL IT OVER. THERE WAS NO IMPACT ON PATIENT OUTCOME. TROUBLESHOOTING INFORMATION WAS PROVIDED. NETWORK DEVICE INTERFACE (NDI) TOOLBOX CONFIRMED THAT THE ISSUE WAS CAUSED BY AN ERRONEOUS ERROR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362128 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female