BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND XT 4CH COMBO PKG

    MDR report key: 1211049 · Received October 24, 2008

    Report

    Report Number
    1022819-2008-00300
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVALUATION. THE DEVICE EVALUATION AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS BEING TREATED USING THE PREMOD ELECTROTHERAPY WAVEFORM WITH 2 INCH DIAMETER ELECTRODES. THE CLINICIAN ADJUSTED THE TREATMENT INTENSITY TO PATIENT TOLERANCE. THE PATIENT DID NOT EXPRESS DISCOMFORT. THE CLINICIAN SET THE TREATMENT TIME TO 15 MINUTES AND STARTED THE TREATMENT. THE PATIENT IMMEDIATELY COMPLAINED THAT THE UNIT WAS GRABBING OR JOLTING AND IT WAS UNCOMFORTABLE. THE TREATMENT WAS STOPPED AND THE ELECTRODES REMOVED. NO INJURY WAS SEEN OR NOTED, BUT THE PATIENT HAS NOT RETURNED FOR ADDITIONAL TREATMENT. THE PHYSICAL THERAPIST FELT THERE HAD BEEN PROBLEMS WITH THIS UNIT, BUT DID NOT GO INTO DETAIL. THE LEAD WIRES WILL BE RETURNED WITH THE UNIT AND THE ELECTRODES WERE THROWN AWAY. ADDITIONAL INFORMATION WAS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 4CH COMBO PKG IPF, IMG, GZJ, GZI IPF CHATTANOOGA GROUP 2760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention