BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, 9733214, REDUCING 2.2MM

    MDR report key: 23290800 · Received October 15, 2025

    Report

    Report Number
    3004785967-2025-00654
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: NO PARTS WERE RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES B17, C20, AND D15 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING THE BIOPSY, THE NEEDLE-REDUCING TUBE WAS NOT PLACED, WHICH WAS NOT NOTICED BY ANYONE IN THE CASE. THE SURGEON BELIEVES THAT BECAUSE OF THIS, A VESSEL WAS NICKED AND CAUSED BLEEDING. THERE WAS NO SURGICAL DELAY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE DID IN FACT USE A REDUCING TUBE WHILE PERFORMING THE ACTUAL INSERTION OF THE NEEDLE. THE ONLY TIME THE REDUCING TUBE WAS NOT USED WAS WHILE THE DURA MATER WAS BEING ACCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993270 TUBE, 9733214, REDUCING 2.2MM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) 9733214 -

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other