BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 8630379 · Received May 21, 2019

    Report

    Report Number
    1723170-2019-02534
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    May 16, 2019
    Report Date
    September 16, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 960-537, SERIAL/LOT #: (B)(4). DEVICE EVALUATION: ANALYSIS WAS COMPLETED FOR THE ARTICULATING ARM. THE REPORTED ISSUE WAS ABLE TO BE DUPLICATED THROUGH VISUAL/PHYSICAL EXAMINATION AND FUNCTIONAL TESTING. THE HANDLE OF THE RETURNED ARTICULATING ARM HAS BROKEN LOOSE AND SPINS FREELY. IT WAS DETERMINED THAT THERE WAS A MECHANICAL FAILURE WITH THE ARTICULATING ARM. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ARTICULATING ARM WAS RECEIVED BUT WAS UNDER ANALYSIS AT THE TIME OF FILING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 960-537 , SERIAL/LOT #: UNKNOWN. ADDITIONAL INFORMATION: FACILITY INFORMATION HAS BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: INITIAL REPORTER INFORMATION HAS BEEN UPDATED. REPORT SOURCE FIELDS HAVE BEEN UPDATED. CORRECTION: DEVICE MODEL # AND CATALOG # UPDATED TO PROPER VALUE. USAGE OF DEVICE UPDATED TO PROPER VALUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. UNIQUE DEVICE IDENTIFICATION (UDI) UNAVAILABLE. DEVICE MANUFACTURING DATE UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS STATED THAT THE ARTICULATING ARM WAS LOOSE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ARM DID NOT WORK BECAUSE IT WAS NOT POSSIBLE TO FIX IT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423470 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9732585

    Patients

    Seq Age Sex Outcome Treatment
    1