BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT XT

    MDR report key: 2954138 · Received October 24, 2007

    Report

    Report Number
    1022819-2007-00003
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED A SPIKE IN ELECTROTHERAPY OUTPUT THAT RESULTED IN A MINOR SKIN BURN BENEATH THE ELECTRODES, AND PROVOKED THE PT TO HAVE A PANIC ATTACK. THE PT'S DIABETES MAY HAVE INCREASED SUSCEPTIBILITY TO SKIN BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT XT POWER MUSCLE STIMULATOR GZJ CHATTANOOGA GROUP 2760

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other