BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 2102544 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01812
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    DURING AN RF PROCEDURE, THE PT FELT UNINTENDED SENSORY STIMULATION AT ZERO VOLTS WHEN THE START BUTTON ON THE SENSORY STIMULATION SCREEN WAS TURNED ON. THERE WAS NO REPORTED CLINICAL EFFECT ON THE PT. THE PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT AND WITH NO DELAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK