BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE CRANIAL REFERENCE FRAME

    MDR report key: 20514961 · Received October 23, 2024

    Report

    Report Number
    1723170-2024-03271
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    July 31, 2024
    Report Date
    October 23, 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, H6: THE FRAME, LOT NUMBER: 190917, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WAS NO APPARENT DAMAGE TO THE CABLE OF THE RETURNED FRAME, AS WAS REPORTED, BUT THE FRAME HAD NO TRACKING WHEN CONNECTED TO A KNOWN GOOD SYSTEM. NO LED'S WERE FIRING AND THE FRAME DID NOT DISPLAY A LIGHTED STATUS ON THE TOOL INTERFACE UNIT (TIU) INDICATING A LIKELY OPEN IN THE CABLE. CODES B01, C02 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 THE CABLE COATING OF THE INSTRUMENT WAS PEELING. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE CAUSE OF THE PEELING WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365910 ACTIVE CRANIAL REFERENCE FRAME NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733881 190917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown