BEUDAMED
    FDA Adverse Event Other Summary report: N

    RS-TENS PLUS

    MDR report key: 2132697 · Received June 10, 2011

    Report

    Report Number
    1644243-2011-00007
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    RS MEDICAL
    Product Code
    GZJ
    PMA / PMN Number
    K050740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; NO DEVICE DEFECT OR NONCONFORMANCE IS INDICATED FROM THE EVENT DESCRIPTION. THE ELECTRODE LEAD WIRES ARE DETACHABLE FROM THE DEVICE BY DESIGN. DEVICE LABELING DESCRIBES AND ILLUSTRATES HOW TO CONNECT THE ELECTRODE LEAD WIRES TO THE ADHESIVE ELECTRODE PADS. THE EVENT DESCRIPTION SUGGESTS THAT PT MOVEMENT LEAD TO PULLING ON A LEAD WIRE SUCH THAT IT BECAME DISCONNECTED OR PARTIALLY DISCONNECTED FROM A PAD AND THEN MAKING SKIN CONTACT LEADING TO THE PERCEPTION OR SENSATION OF ELECTRIC SHOCK. PT REPORTED PLUGGING THE CONNECTION BACK IN TO RESTORE NORMAL OPERATION. NO SPECIFIC CONCLUSIONS CAN BE DRAWN FROM THE AVAILABLE EVIDENCE.

    Description of Event or Problem · 1

    PT REPORTED RECEIVING AN ELECTRIC SHOCK FROM THE DEVICE. DEVICE IS A NERVE STIMULATOR DESIGNED TO DELIVER ELECTRICAL SIGNALS THROUGH ELECTRODES PLACED ON THE SKIN. PT REPORTED THAT THE WAS DRIVING A VEHICLE AT THE TIME AND ONE OF THE ELECTRODES BECAME UNPLUGGED. PT REPORTED NO ADVERSE MEDICAL EVENT OR INJURY AS A RESULT. PT STATED THEIR CONCERN THAT A TRAFFIC ACCIDENT MIGHT HAVE RESULTED FROM SUCH AN EVENT BUT NO SUCH INCIDENT ACTUALLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RS-TENS PLUS TRANSCUTANEOUS ELECTRICAL NERVE STIM. GZJ RS MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR