BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 1853854 · Received September 7, 2010

    Report

    Report Number
    1811755-2010-01060
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED IF THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    AT THE BEGINNING OF A LUMBAR RF PROCEDURE, WHEN IN STIMULATION MODE, THE PT EXPERIENCED UNINTENTIONAL SENSORY STIMULATION. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED USING THE SAME EQUIPMENT. NO ADDITIONAL TREATMENT OR INTERVENTION WAS REQUIRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF MULTIGEN GENERATION, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK