BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 1905705 · Received November 12, 2010

    Report

    Report Number
    1811755-2010-01694
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K032601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR INVESTIGATION. MAINTENANCE WAS PERFORMED ACCORDING TO THE MOST RECENT REVISION AND THE PRODUCT WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING AN RF PROCEDURE, WHEN THE GENERATOR SWITCHED TO MOTOR STIMULATION MODE, THE PT EXPERIENCED UNINTENTIONAL SENSORY STIMULATION. THE PROCEDURE WAS COMPLETED USING THE SAME EQUIPMENT AND WITHOUT DELAY. THERE WAS NO INTERVENTION OR ADDITIONAL TREATMENT REQUIRED. THERE ARE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK