BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS

    MDR report key: 1027642 · Received April 10, 2008

    Report

    Report Number
    1022819-2008-00120
    Event Type
    Other
    Date Received
    April 10, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 6, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    PATIENT RECEIVED AN UNINTENDED OUTPUT DURING ELECTROTHERAPY TREATMENT. THE PATIENT, WITH A MEDICAL HISTORY OF STROKE AND PARKINSON'S, WAS RECEIVING ELECTROTHERAPY TREATMENT ON THE BICEPS. DURING THE TREATMENT, THE PATIENT COMPLAINED OF EXCESSIVE OUTPUT. THE CLINICIAN TERMINATED THE TREATMENT AND INSPECTED THE TREATMENT AREA. THE PATIENT DID NOT SUFFER ANY INJURY FOR THE SUSPECTED INCIDENT. THE CLINICIAN PRESCRIBED THE VMS WAVEFORM FOR THE PATIENT'S ALIMENT. THE WAVEFORM WAS TO BE APPLIED USING 2 INCH DIAMETER ADHESIVE ELECTRODES. THE VMS WAVEFORM WAS TO HAVE AN INTENSITY OF .1. AS THE CLINICIAN BEGAN THE TREATMENT, THE INTENSITY WAS ADJUSTED TO THE PRESCRIBED SETTINGS. HOWEVER, AS THE INTENSITY WAS ADJUSTED, THE PATIENT BEGAN TO COMPLAIN OF EXCESSIVE OUTPUT. THE PATIENT ROUTINELY TAKES THIS TREATMENT. THE PATIENT HAS NOT SUFFERED DISCOMFORT DURING THE PAST TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS GZJ, STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF GZJ CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 Other