BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA GENISYS 2CH COMBO

    MDR report key: 1181025 · Received September 23, 2008

    Report

    Report Number
    1022819-2008-00208
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    February 5, 2007
    Report Date
    February 5, 2007
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMG
    PMA / PMN Number
    K031077
    Removal / Correction Number
    1022819-11/15/2007-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF SHOCK DURING MUSCLE STIMULATOR THERAPY. THERAPY WAS BEING ADMINISTERED ON CHANNEL 2.

    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