BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND XT 2 CH STIM

    MDR report key: 1190302 · Received October 6, 2008

    Report

    Report Number
    1022819-2008-00153
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K031077
    Removal / Correction Number
    1022819-11/15/2007-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REC'D A JOLT SENSATION AT THE BEGINNING OF AN ELECTROTHERAPY TREATMENT. THE PT WAS RECEIVING ELECTROTHERAPY TREATMENT IN THE AREA OF THE CALF MUSCLE. THE CLINICIAN STARTED THE TREATMENT, AND THE PT BEGAN COMPLAINING OF A JOLTING SENSATION NON-TYPICAL OF AN ELECTROTHERAPY TREATMENT. THE CLINICIAN TERMINATED THE TREATMENT. THE CLINICIAN PRESCRIBED THE RUSSIA WAVEFORM FOR THE ELECTROTHERAPY TREATMENT. THE OUTPUT OF THE WAVEFORM WAS DETERMINED TO BE LESS THAN .1 WHEN THE EVENT OCCURRED. THE TREATMENT TIME WAS PRESCRIBED TO BE 15 MINS. THE CLINICIANS APPLIED THE TREATMENT USING SELF ADHESIVE ELECTRODES. THE ELECTRODES FOR THIS PT HAD BEEN USED LESS THAN 5 TIMES PRIOR TO THIS INCIDENT. THE ELECTRODE SIZE WAS 2X2 INCHES. THE PT DID NOT RECEIVE AN INJURY AS A RESULT OF THE INCIDENT. THE PT HAD REC'D ELECTROTHERAPY TREATMENT WITHOUT REPORTED ISSUE PRIOR TO THIS EVENT. THE CLINICIAN DID REPORT THAT THE DEVICE HAD TO HAVE THE POWER RECYCLED EARLIER. AFTER THE POWER WAS RECYCLED, THE DEVICE OPERATED WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 2 CH STIM IPF, GZJ, GZI IPF CHATTANOOGA GROUP 2763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention