BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 20011635 · Received August 21, 2024

    Report

    Report Number
    1723170-2024-02238
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 21, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOREIGN COUNTY - 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

    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 HERNIA PROCEDURE. IT WAS REPORTED THAT DURING THE SURGERY, THE NAVIGATION ANTENNA MOVED SLIGHTLY AND WAS RE-TIGHTENED, BUT THE SCREW INSERTION WAS RESUMED AFTER IT WAS DETERMINED THAT THERE WAS NO SIGNIFICANT MISALIGNMENT ON THE IMAGES. AFTER INSERTION, 3D IMAGING WAS TAKEN BY THE IMAGING SYSTEM, AND SEVERAL PIECES WERE FOUND TO HAVE DEVIATED FROM THE PEDICLES, SO REINSERTION WAS PERFORMED AND THE FINAL TIGHTENING WAS PERFORMED. THERE WAS A DELAY OF LESS THAN ONE HOUR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO BROKEN PRODUCTS OR FRAGMENTS WERE LEFT INSIDE OF THE PATIENT. NO NEW SURGERY HAS BEEN SCHEDULED FOR THE REMOVAL OF THE IMPLANT. THE PROBABLE CAUSE OF THE REPORTED EVENT WAS THAT THE CAUSE WAS A MISALIGNMENT IN NAVIGATION DUE TO THE ANTENNA MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007808 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown