BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS 2CH

    MDR report key: 1012393 · Received March 7, 2008

    Report

    Report Number
    1022819-2008-00060
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING UNIT RETURN AND EVALUATION.

    Description of Event or Problem · 1

    CLINICIAN CONDUCTED ELECTROTHERAPY TREATMENT ON THE KNEE AREA. THE PATIENT COMPLETED THE 8 MINUTE TREATMENT AND THE CLINICIAN STOPPED THE TREATMENT. THE CLINICIAN NOTED ANY BURNS POST-TREATMENT. THE PATIENT RECEIVED A SHOCK IN THE TREATMENT AREA OF THE ELECTRODES. THE PATIENT DID NOT REQUIRE ANY IMMEDIATE OR KNOWN POST MEDICAL TREATMENT FOR THE SHOCK. THE PATIENT HAD RECEIVED ELECTROTHERAPY TREATMENTS (6) PRIOR TO THIS INCIDENT. THE CLINICIAN TREATED THE PATIENT USING ELECTROTHERAPY. THE TREATMENT TIME WAS SET FOR 15 MINUTES. THE TREATMENT PARAMETERS PRESCRIBED ARE 4 POLE INTERFERENTIAL, CONSTANT VOLTAGE FREQUENCY. INTENSITY COULD NOT BE PROVIDED BY THE ATTENDING CLINICIAN. THE ELECTRODES WERE PREVIOUSLY USED ON THE PATIENT. THE ELECTRODES WERE VALUTRODE FROM AXLEGAARD ELECTRODES. THE CLINICIAN INDICATED THAT THE PATIENT WAS NOT HOLDING THE PATIENT SWITCH. THE CLINICIAN DID NOT INDICATE ANY CHANGES IN THE TREATMENT SETTINGS. THE PATIENT DOES HAVE ANY PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS 2CH POWER MUSCLE STIMULATOR IPF CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other