BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH INAV PORTABLE SYSTEM

    MDR report key: 3150801 · Received June 6, 2013

    Report

    Report Number
    1723170-2013-00407
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT PRESENT. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTED COUNTRY WHERE THE REPORTED EVENT OCCURRED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE ARTICULATING ARM ASSOCIATED WITH THE NAVIGATION SYSTEM WAS NOT TIGHTENING OR LOOSENING CORRECTLY. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250331 STEALTH INAV PORTABLE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. INAV PORTABLE

    Patients

    Seq Age Sex Outcome Treatment
    1