BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMA 5 T.E.N.S. UNIT

    MDR report key: 1610547 · Received February 16, 2010

    Report

    Report Number
    MW5014810
    Event Type
    Injury
    Date Received
    February 16, 2010
    Date of Event
    February 14, 2010
    Report Date
    February 16, 2010
    Manufacturer
    PAIN MANAGEMENT TECHNOLOGIES
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DEPARTMENT OF (B) (6) GAVE ME A PAIN MANAGEMENT TECHNOLOGIES ULTIMA 5 T.E.N.S. UNIT TO HELP WITH MY CHRONIC BACK PAIN. GENERALLY IT WORKS WELL, BUT ON A NUMBER OF DAYS, THE LEADS FROM THE UNIT PULL FROM THE PADS - PLACED ON MY MID-BACK- AND DELIVER VERY PAINFUL ELECTRIC SHOCKS UNTIL I CAN TURN OFF THE DEVICE OR PULL THE LEADS OUT OF MY SHIRT. THE PADS ARE PLACED ON MY MID-BACK ON OPPOSITE SITES OF MY SPINE. THE LEADS GO DOWN TO MY PANTS AND ARE ROUTED AROUND MY SIDE TO THE T.E.N.S. DEVICE, WHICH IS ATTACHED TO MY BELT. THE LEADS WILL PULL AWAY AT VARIOUS TIMES, SOMETIMES JUST BECAUSE I HAVE SHIFTED MY SEATED POSITION. I THINK THE SOLUTION TO THIS PROBLEM IS TO ADD THE MALE CONNECTORS TO THE PAD LEADS, AND THE CABLE LEADS SHOULD BE FEMALE. THIS WILL PREVENT THE MALE LEADS TO TOUCH THE SKIN WHILE ENERGIZED SINCE THE PADS IMMEDIATELY LOSE POWER AS THEY ARE DISCONNECTED. I UNDERSTAND THAT THIS CHANGE WILL RAISE THE COSTS OF THE PADS, BUT I THINK THIS SOLUTION WILL MAKE THIS PRODUCT SAFER. FREQUENCY: AS NEEDED. DATES OF USE: (B) (6) 2009 -- (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: CHRONIC DEGENERATIVE DISK DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA 5 T.E.N.S. UNIT T.E.N.S. UNIT GZJ PAIN MANAGEMENT TECHNOLOGIES CB12-0431

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability