BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    70 DEG CURVED SUCTION, AXIEM

    MDR report key: 21667483 · Received March 21, 2025

    Report

    Report Number
    1723170-2025-01440
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    October 16, 2024
    Report Date
    March 21, 2025
    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: ANALYSIS WAS PERFORMED FOR PRODUCT: 9733450, LOT NUMBER: 240404. IT WAS REPORTED THAT THE RETURNED CURVED SUCTION WAS NOT ABLE TO VERIFY WHEN CONNECTED TO A KNOWN GOOD SYSTEM. THE SUCTION DISPLAYED A DIVOT ERROR OF 2.3MM TO 2.4MM. CODES B01, C13 AND D02 ARE APPLICABLE TO THIS ANALYSIS. A05: APPLICABLE TO THE DEFORMATION OF THE CURVED SUCTION. A0709: APPLICABLE TO VERIFICATION COULD NOT BE PERFORMED. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT VERIFICATION COULD NOT BE PERFORMED DUE TO THE DEFORMATION OF THE CURVED SUCTION. THE NETWORK CONNECTOR BROKE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862584 70 DEG CURVED SUCTION, AXIEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733450 240404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown