BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19144128 · Received April 19, 2024

    Report

    Report Number
    1723170-2024-01118
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 22, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821. H3: THE SYSTEM WAS SERVICED IN THE FIELD, AND THE CAMERA WAS REPLACED. CODES B01, C08, D02 ARE APPLICABLE TO THIS ANALYSIS. H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A1102 WAS CODED FOR THE LOCALIZER FAULTY MESSAGE. A05 WAS CODED FOR THE CAMERA NOT RECOGNIZING. 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) THE PRODUCT ID: 9735821, LOT NUMBER: P900766, RETURNED TO THE MANUFACTURER AND ANALYSIS CONFIRMED THE REPORTED EVENT. THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD MANY NICKS AND SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO MAY OF 2018 AND INTERMITTENT ILLUMINATOR CURRENT LOW DATING BACK TO OCTOBER OF 2019. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE PSU FAILED AN ACCURACY TEST (AAK) AT .762 MILLIMETERS (MM) WITH A PASSING THRESHOLD OF .250MM. THE PSU ALSO HAD LINE SEPARATION REPORTED DURING TESTING. PREVIOUSLY REPORTED CODES, B01, C08, AND D02 ARE APPLICABLE TO THIS RETURNED PRODUCT ANALYSIS AS WELL AS NEWLY REPORTED CODES, C02 AND C07. 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 CAMERA WAS NOT SEEING THE REFERENCE FRAME. IT WOULD COME UP WITH LOCALIZER FAULTY. NO PATIENT WAS PRESENT. TROUBLESHOOTING INFORMATION WAS PROVIDED. THE CAMERA WAS FOUND TO BE FAULTY. THE CAMERA WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431550 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

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