BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 23303198 · Received October 15, 2025

    Report

    Report Number
    1723170-2025-03468
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 30, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    UDI-DI
    00643169029750
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: CORRECTION TO CONTINUATION OF D10 IN INITIAL REGULATORY REPORT SUBMITTED FOR THIS EVENT (1723170-2025-03468): SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733438, SERIAL/LOT#: (B)(6), UDI#: (B)(4); PRODUCT ID: 9731460, PRODUCT ID: 9733823, H2: PLEASE SEE THE ADDITIONAL CODES SECTION FOR NEW ANNEX G CODES. ANNEX G CODE G02004 REPRESENTS PRODUCT ID: 9733823. ANNEX G CODE G04068 REPRESENTS PRODUCT ID: 9731460. 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 RETURNED CABLE 9733823, LOT NUMBER: 160413, UDI: (B)(4) HAD NO APPARENT PHYSICAL DAMAGE AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. NO PROBLEM WAS FOUND. CODE C19, D14 AND PREVIOUSLY REPORTED CODE B01 ARE APPLICABLE TO THIS ANALYSIS. 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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733438, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4). H3, H6: A MANUFACTURER REPRESENTATIVE WENT TO THE SYSTEM TO TEST THE EQUIPMENT. THE MICRO COMMUNICATION CABLE AND THE CAMERA WERE REPLACED. CODES B01, C08, C13, AND D02 ARE APPLICABLE TO THIS ANALYSIS. H3, H6: THE CAMERA WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT POSITION SENSOR CURRENT OUT OF RANGE. OTHERWISE, THE CAMERA WAS FOUND TO BE FULLY FUNCTIONAL ON THE TEST BENCH DURING TESTING. CODES B01, C02, AND D02 ARE APPLICABLE TO THIS ANALYSIS. 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 DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT DURING THE NAVIGATION SYSTEM AND SCOPE LINK, THE BRACKET WAS RECOGNIZED AND COMMUNICATED WELL AT THE BEGINNING OF THE OPERATION, BUT A RECOGNITION DEFECT OCCURRED IN THE BRACKET. THE DEVICE DID NOT RESPOND AT ALL, SO COMMUNICATION WAS POOR. THERE WAS NO RESPONSE EVEN WHEN THE DEVICE WAS RESTARTED. THE OPERATION WAS COMPLETED WITHOUT A LINK. THEY COULD NOT USE THE MICRO BRACKET. THIS ISSUE CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337701 CART 9734056 S7 STAFF SHRT 100-120V INTL NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 9734056 00643169029750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown