BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 22784208 · Received August 12, 2025

    Report

    Report Number
    1723170-2025-02959
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 30, 2025
    Report Date
    November 5, 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

    H3,H6: THE SYSTEM CONTROL UNIT (SCU) 9733438 CAMERA, LOT NUMBER: T304305, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. A CHECK OF THE EVENT LOG DID NOT SHOW ANY ADVERSE EVENTS. THE SCU WAS ABLE TO TRACK INSTRUMENTS FOR ALL THREE PORTS WITHOUT ISSUE. NO PROBLEM WAS FOUND. CODE C19, D14 AND PREVIOUSLY REPORTED CODES 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

    H3, H6: THE 9733580 BREAK OUT BOX CABLE, LOT 160915 WAS RETURNED FOR EVALUATION. ANALYSIS FOUND AN ELECTRICAL FAILURE. PORT B OF THE RETURNED BREAK OUT BOX WAS FOUND TO BE NONFUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. ALL OTHER PORTS WERE FOUND TO BE NORMAL. CODES C02 AND PREVIOUSLY REPORTED B01, 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.

    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 #: UNKNOWN, UBD:- , UDI#:-; PRODUCT ID: 9733580, SERIAL/LOT #: UNKNOWN, UBD:- , UDI#:- H3, H6: A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE SCU AND THE BREAKOUT BOX CABLE WERE REPLACED. CODES B01, C13, 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.

    Additional Manufacturer Narrative · 0

    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 REGISTRATION AND THE STERILE SETUP, THE ACTIVE FRAME WAS RECOGNIZED, AND THE NAVIGATION SYSTEM WAS IN USE. HOWEVER, PARTWAY THROUGH, TRACKING THE ACTIVE FRAME BECAME UNRELIABLE. WHILE IT WAS BRIEFLY RECOGNIZED, IT FAILED TO BE RECOGNIZED FOR MOST OF THE TIME. THE PASSIVE PROBE TRACKED WITHOUT ISSUE. BOTH THE STERILE AND NON-STERILE ACTIVE FRAMES WERE TESTED, BUT NO IMPROVEMENT WAS OBSERVED. RESTARTING THE SYSTEM ALSO DID NOT RESOLVE THE ISSUE. NAVIGATION WAS ABORTED, AND THE SURGERY WAS COMPLETED WITHOUT NAVIGATION. POST-SURGERY, THE SYSTEM WAS CHECKED BUT REMAINED UNSTABLE. DURING MAINTENANCE, IT WAS DETERMINED THAT THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU), BREAKOUT BOX, AND ACTIVE FRAME × 2 HAD BEEN DISCONTINUED, LEADING TO A TRANSITION TO THE PASSIVE FRAME. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE RECOGNITION FAILURE AND DEFECT OCCURRED DURING USE OF THE CRANIAL FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099757 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 SEE H11.