BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRA GENISYS 2CH COMBO

    MDR report key: 1171157 · Received September 23, 2008

    Report

    Report Number
    1022819-2008-00197
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMG
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING-DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS.

    Description of Event or Problem · 1

    A MALE PT, WAS BEING TREATED IN THE SHOULDER AREA FOR SHOULDER PAIN WITH ELECTROTHERAPY WHEN THE PT REC'D A SKIN BURN. SEVEN MINUTES INTO A 20 MINUTES TREATMENT, THE PT TERMINATED THE ELECTROTHERAPY TREATMENT DUE TO DISCOMFORT. THE ATTENDING CLINICIAN REMOVED THE TREATMENT ELECTRODES AND NOTED A 2ND DEGREE SKIN BURN LESS THAN 2 CM IN DIAMETER UNDER ONE OF THE TREATMENT ELECTRODES. THE CLINICIAN HAD PRESCRIBED THE INTERFERENTIAL ELECTROTHERAPY WAVEFORM TO TREAT THE PT. AT THE TIME OF THE TERMINATION OF THE TREATMENT, THE OUTPUT SETTING WAS SET TO 14 VOLTS. THE FREQUENCY SETTING WAS AT THE DEFAULTS. THE PT DID NOT REQUEST OR SEEK ATTENTION FOR THE INJURY. BECAUSE THE PT WAS YOUNG AND IN GOOD HEALTH, THE CLINICIAN DID NOT CONSIDER THIS A SERIOUS INJURY. THE CLINICIAN ALSO COMMENTED THAT IT SEEMS LIKE THE NEW DEVICE REQUIRES A LOWER SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS 2CH COMBO IMG; GZI, GZJ, HCC, IPF IMG CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention