BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT 1.5

    MDR report key: 2636089 · Received July 2, 2012

    Report

    Report Number
    1721293-2012-00003
    Event Type
    Injury
    Date Received
    July 2, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    EMPI, INC.
    Product Code
    NYN
    PMA / PMN Number
    K061650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE, LEADWIRE, AND ELECTRODES WERE INVESTIGATED. DEVICE AND ELECTRODES MET SPECIFICATIONS, THE LEADWIRE DEVICE CONNECTION WAS INTERMITTENT. AN INTERMITTENT LEADWIRE COULD HAVE CAUSED A SENSATION OF SURGING CURRENT: THE DEVICE IS DESIGNED TO RAMP DOWN TO A SAFE LEVEL WHEN THE CONNECTION BETWEEN THE DEVICE AND THE ELECTRODE IS OPEN, AND TO RAMP BACK UP TO THE PREVIOUSLY SET LEVEL WHEN THE CONNECTION IS RESTORED. THIS SHOULD NOT HAVE CAUSED ANY PHYSICAL HARM TO THE PATIENT BECAUSE THE ENERGY DELIVERED WOULD NOT EXCEED THE PREVIOUSLY SET LEVEL, BUT THE RAMPING UP SENSATION COULD BE STARTLING.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS SHOCKED WHILE WEARING THE SELECT 1.5 DEVICE. THE PATIENT IS (B)(6) AND USES THE DEVICE 24/7. SHE WAS WEARING THE DEVICE IN SCHOOL AND EXPERIENCED A SHARP SHOCK DOWN BOTH LEGS TO HER KNEES. SHE WAS THEN TAKEN TO THE EMERGENCY ROOM WHERE THE DR PLACED HER IN THE HOSPITAL. THE PATIENT WAS USING THE PROGRAM HIP/BACK INTENSITY 40.0. ONLY ONE LEADWIRE WAS USED, AND THE ELECTRODES WERE PLACED ON EACH SIDE OF HER SPINE ON HER LOWER BACK HIP AREA. SHE HAS NO METAL IN HER BODY AND NEVER HAD SURGERY ON HER BACK; SHE USED THE DEVICE FOR PAIN MANAGEMENT. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND HAS BEEN IN A WHEELCHAIR MORE THAN OUT, SHE IS VERY WEAK IN BOTH LEGS AND IS STILL HAVING PAIN. THE PATIENT INDICATED THAT SHE WILL NOT USE THE UNIT ANY LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT 1.5 SELECT 1.5 NYN EMPI, INC. 199584-001

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| O