BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHATTANOOGA INTELECT LEGEND

    MDR report key: 3281199 · Received July 24, 2013

    Report

    Report Number
    9616086-2013-00012
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    May 16, 2011
    Manufacturer
    DJO, LLC
    Product Code
    IMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS INITIATED BY REGULATORY AFFAIRS ON OUR AWARE DATE OF (B)(4) 2013. FOLLOW UP REPORTS WILL BE PROVIDED AS MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PT WAS GIVEN A TREATMENT USING ELECTRONIC STIMULATION AND THE PT REPORTED RECEIVING A SHOCK. THE PT IS NOW ALLEGING INJURIES AS A RESULT OF THE SHOCK. DJO, LLC BECAME AWARE OF THE REPORTED EVENT ON (B)(4) 2013. THE DEVICE HAS NOT BEEN RETURNED TO DJO, LLC FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347154 CHATTANOOGA INTELECT LEGEND INTELECT LEGEND IMG DJO, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other