BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLANAR BALL PROBE

    MDR report key: 21713560 · Received March 27, 2025

    Report

    Report Number
    1723170-2025-01481
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    October 4, 2024
    Report Date
    March 27, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K972398
    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: 960-559, LOT NUMBER: 230322. IT WAS REPORTED THAT THE RETURNED PROBE DID NOT APPEAR TO HAVE ANY PHYSICAL DAMAGE, BUT WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE DISPLAYED A HIGH GEOMETRY ERROR ATTRIBUTED TO MARKER #2. WITH THIS MARKER REMOVED, THE PROBE HAD NORMAL TRACKING AND VERIFICATION. CODES B01, C07 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING INSPECTION, IT WAS DISCOVERED THAT THE PROBE WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432435 PASSIVE PLANAR BALL PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 960-559 230322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown