BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION, INC

    MDR report key: 20247563 · Received September 18, 2024

    Report

    Report Number
    1723170-2024-02748
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 28, 2024
    Report Date
    December 17, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    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) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES: B17, C20, D15 G2) FOREIGN COUNTRY: JAPAN. 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

    H2) THE INSTRUMENT RETURNED TO THE MANUFACTURER ON 12-NOVEMBER-2024 AND IS PENDING ANALYSIS. CODES B21, C21, AND D16 ARE APPLICABLE. 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.

    Additional Manufacturer Narrative · 0

    H3) THE PROBE WAS RETURNED FOR ANALYSIS. FUNCTIONAL TESTING DETERMINED THE PROBE WAS FUNCTIONING AS DESIGNED. 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 INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING THE SURGERY, A COMMUNICATION FAILURE OCCURRED SUDDENLY WITH THE CAMERA. IT WAS RESTORED AFTER A WHILE. WHEN IT WAS RESTARTED AFTER THE OPERATION, COMMUNICATION FAILURE OCCURRED AGAIN. IT WAS STARTED UP AGAIN AND IT WAS RESTORED. AN ACTIVE PROBE AND ACTIVE FRAME WERE USED. WHEN TESTING, IT WAS FOUND THAT WHEN AN ACTIVE PROBE WAS CONNECTED, A COMMUNICATION ERROR OCCURRED SEVERAL TIMES, MAKING ALL INSTRUMENTS UNUSABLE. THE ACTIVE PROBE AND FRAME WERE REMOVED, AFTER CONFIRMING THAT THE CAMERA COMMUNICATION HAD BEEN RESTORED, RECONNECTED IT TO RESTORE OPERATION. OTHER ACTIVE PROBES WERE FINE. THERE WERE NO PROBLEMS WITH THE POSITIONING SENSOR UNIT (PUS) EITHER. THE ACTIVE PROBE WAS REPLACED AND IN A SEPARATE CASE, THE TIP OF A CERVICAL PROBE BECAME DEFORMED AFTER BEING USED ON A PATIENT WITH STIFF BONES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360325 MEDTRONIC NAVIGATION, INC NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733879 230209

    Patients

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