BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC PROBE 9734680 NAVLOCK

    MDR report key: 9266674 · Received November 1, 2019

    Report

    Report Number
    1723170-2019-05434
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 4, 2019
    Report Date
    December 13, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RETURNED FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE THORACIC PROBE 9734680 NAVLOCK (LOT# 180228) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE RETURNED PROBE WAS BENT AS WAS REPORTED. THERE WERE ALSO IMPACT MARKS AT THE BACK END CAUSING FIT ISSUES WITH THE MATING TRACKER. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE TIP OF THE THORACIC PROBE WAS BENT AND THAT THE PROBE WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061648 THORACIC PROBE 9734680 NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734680 180228

    Patients

    Seq Age Sex Outcome Treatment
    1