BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RS-TENS PLUS

    MDR report key: 1894246 · Received November 3, 2010

    Report

    Report Number
    1644243-2010-00013
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    January 15, 2010
    Report Date
    November 3, 2010
    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

    PT'S UNDERLYING CERVICAL CONDITION COULD HAVE CAUSED THE REPORTED EVENT. ALSO POSSIBLE THAT ELECTRODE POSITIONED ON LEFT SIDE MIGHT HAVE PARTIALLY LIFTED WHEN PT TURNED THEIR HEAD CAUSING THE EFFECTIVE SURFACE AREA IN CONTACT WITH THEIR SKIN TO DECREASE THEREBY INCREASING CURRENT DENSITY CAUSING REPORTED 'JOLT' THAT PT FELT. PT DID NOT REPORT ANY SIMILAR TYPE OF EVENTS AFTERWARDS. THE STIMULATOR WAS NEVER RECEIVED BY RS MEDICAL PREVENTING DEVICE EVAL. (B)(4).

    Description of Event or Problem · 1

    PT REPORTED RECEIVING A JOLT FROM THE RS TENS PLUS STIMULATOR WHEN DRIVING. THE EVENT CAUSED PT'S LEFT ARM TO TEMPORARILY SPASM. PT STATED IT COULD HAVE RESULTED IN A CAR ACCIDENT. PT WAS USING THE STIMULATOR TO TREAT NECK PAIN WITH ELECTRODE LOCATIONS ON THE LEFT SIDE OF HER NECK UNDER HER EAR AND ON THE LEFT SIDE BETWEEN NECK AND SHOULDER, ONE ON THE CENTER OF THE BACK OF THE NECK AND ONE ON THE SHOULDER BLADE. PT STATED SHE FELT THE STRONG SENSATION LIKE A JOLT AS IF THE TENS WAS TOO HIGH OF AN INTENSITY WHEN SHE TURNED HER NECK TO THE RIGHT. PT TURNED OFF THE STIMULATOR, STOPPED USING THE STIMULATOR AFTER THAT EXPERIENCE. PT STATED SHE SENT THE DEVICE BACK IN TO THE COMPANY. THE PT REPORTED ONLY USING THE DEVICE FOR APPROXIMATELY ONE WEEK. THE COMPANY NEVER RECEIVED THE STIMULATOR BACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR