BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS

    MDR report key: 1016332 · Received March 21, 2008

    Report

    Report Number
    1022819-2008-00105
    Event Type
    Other
    Date Received
    March 21, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVALUATION OF THE DEVICE. TYPE OF DEVICE: IPF, STIMULATOR, MUSCLE, POWERED, 890.5858; GZI, STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL, 882.5810

    Description of Event or Problem · 1

    PATIENT WAS RECEIVED A BURN DURING A 4 POLE INTERFERENTIAL ELECTROTHERAPY TREATMENT (IFU, 4P). THE PATIENT WAS BEING TREATED FOR A HIGH ANKLE SPRANG. THE CLINICIAN PRESCRIBED THE IFC, 4P OUTPUT TO BE SET AT LESS THAN 50MA. THE FREQUENCY SETTING WAS 80-150HZ. THE TREATMENT DURATION WAS FOR 20 MINUTES. THE TREATMENT WAS BEING APPLIED VIA NEW 2X2" DISPOSABLE ELECTRODES. TEN MINUTES INTO THE TREATMENT THE PATIENT EXPRESSED DISCOMFORT. THE CLINICIAN STOPPED THE TREATMENT. UPON THE TERMINATION OF THE TREATMENT THE CLINICIAN REMOVED THE ELECTRODES AND DISCOVERED TWO BURNS IN THE TREATMENT AREA OF THE ELECTRODES. THE FIRST NOTED BURN WAS A 3RD DEGREE IN SEVERITY. THE SIZE OF THE BURN WAS ESTIMATED TO BE ONE CENTIMETER SQUARED. THE SECOND NOTED BURN WAS A 2ND DEGREE IN SEVERITY. THE SIZE OF THE BURN WAS ESTIMATED TO BE 2CM SQUARED. THE PATIENT HAD RECEIVED ELECTROTHERAPY TREATMENT BY THIS CLINIC PRIOR TO THIS EVENT. NO COMPLICATIONS WERE NOTED DURING PREVIOUS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS GZJ, STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF, 882.5810 GZJ CHATTANOOGA GROUP 2764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other