BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, BONE GROWTH, NON-INVASIVE

    MDR report key: 2803022 · Received October 17, 2012

    Report

    Report Number
    3008524126-2012-00027
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LOF
    PMA / PMN Number
    P850007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALL FROM PT COMPLAINING OF BURNING, UNIT GETTING HOT AND NOW STATES SHOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULATOR, BONE GROWTH, NON-INVASIVE SPINAL STIMULATION DEVICE LOF ORTHOFIX INC. 652212-0009

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other