BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV CD HORIZON® SOLERA¿ MAST 4.75 DRIVER

    MDR report key: 3013770 · Received March 20, 2013

    Report

    Report Number
    1723170-2013-00200
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE WAS UNABLE TO PROVIDE ANY PATIENT DEMOGRAPHIC INFORMATION. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE USING POWER EASE, THE TIP OF THE SOLERA STANDARD DRIVER HAD BECOME BENT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115340 NAV CD HORIZON® SOLERA¿ MAST 4.75 DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 111130

    Patients

    Seq Age Sex Outcome Treatment
    1