BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHATANOOGA VECTRA NEDEK 2761

    MDR report key: 3040082 · Received April 2, 2013

    Report

    Report Number
    MW5029624
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    DJO GLOBAL
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED PREMODULATED E-STIM AND MH. DURING TREATMENT, THE E-STIM UNIT SHUT DOWN ON CHANNEL ONE AND GAVE THE ERROR MESSAGE "OVER CURRENT." ELECTRODE PLACEMENTS WERE CHECKED AND APPEARED TO HAVE GOOD CONTACT. CHANNEL WAS SHUT OFF AND RESTARTED. FOLLOWING DAY, PT REPORTED THAT SHE HAD DISCOMFORT THE PRIOR DAY AND WAS BURNED BY THE ELECTRIC STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134935 CHATANOOGA VECTRA NEDEK 2761 PREMODULATED ELECTRICAL STIMULATION IPF DJO GLOBAL 2761 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention