BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RS-TENS PLUS

    MDR report key: 1841280 · Received September 17, 2010

    Report

    Report Number
    1644243-2010-00010
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 18, 2010
    Manufacturer
    RS MEDICAL
    Product Code
    GXY
    PMA / PMN Number
    K090951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TENS UNIT WAS RETURNED, TESTED AND MET ALL APPLICABLE QUALITY ASSURANCE SPECIFICATIONS. THE CABLES WERE NOT EXAMINED. THE METAL BELT CLIP IS ISOLATED IN PLASTIC ON THE TENS CASE. THE EXACT CAUSE OF THE REPORTED ELECTRICAL SHOCK IS UNKNOWN. PATIENT REPORTED USING THE TENS FOR 5 DAYS, ABOUT ONE HOUR PER DAY. PATIENT WAS PERSPIRING HEAVILY DUE TO HUMIDITY. FOUR 2.75 INCH DIAMETER ELECTRODES WERE PLACED TO TREAT HIS SHOULDER WITH THE PATIENT CABLE EXTENDING UNDER HIS SHIRT TO THE TENS UNIT. THE TENS UNIT WAS PLACED ON THE PATIENT'S BELT ABOUT 3 INCHES TO THE RIGHT OF HIS NAVEL, UNDER THE ARM SLING WHICH HAD A SPACER OR "SLED" TO KEEP THE SHOULDER POSITION STABLE. THE PATIENT SAID HE DIDN'T RECEIVE THE SHOCK UNTIL HE TOUCHED THE TENS UNIT, LIFTING IT OFF HIS BELT. HE NEEDED TO REACH ACROSS HIS BODY WITH HIS FREE ARM TO LIFT THE TENS UP. BUT THE EXACT CIRCUMSTANCES OF WHERE THE CURRENT PATH CAME FROM IS UNKNOWN. ONE POSSIBILITY IS THAT IN LIFTING THE TENS UNIT WITH THE POWER ON, THE PATIENT PARTIALLY DISLODGED A CABLE AND TOUCHED THE PARTIALLY CONNECTED CABLE PIN WHILE ALSO TOUCHING THE BELT CLIP AS HE HAD ELECTRODES ON HIS BACK. THE 9V BATTERY IN THE TENS POSSIBLY COULD DELIVER THE CURRENT TO MATCH THE PATIENT'S REPORT. ANY INTERACTION OF THE HIGHER CURRENT POWER SOURCE ON THE ELECTRIC WHEELCHAIR IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED RECEIVING A SIGNIFICANT SHOCK FROM METAL TENS BELT CLIP WHEN TRYING TO REMOVE THE DEVICE FROM HIS BELT. PATIENT WAS SEVERAL DAYS POST SHOULDER SURGERY WITH ARM IN SLING AND WAS IN ELECTRIC WHEELCHAIR OUTSIDE ON A HOT HUMID DAY AND WAS PERSPIRING AND AS HE LEANED ON THE DEVICE CABLES HE FELT A LIGHT SHOCK/TINGLING. THE PATIENT WENT TO TAKE OFF THE SLING AND WAS PULLING THE TENS UNIT OFF. AS HE WAS PULLING THE TENS UP HE RECEIVED A SHOCK WHICH FELT LIKE A TASER FROM THE BELT CLIP. AS HE REACTED TO THE SHOCK HE MOVED HIS ARM WHICH WAS RECUPERATING FROM SURGERY WHICH RESULTED IN SORENESS LATER TREATED BY A PHYSICAL THERAPIST. PATIENT CONTACTED HIS PHYSICIAN AND WAS WORRIED THAT HE MAY HAVE INJURED HIS ARM OR DAMAGED HIS SHOULDER. NO DAMAGE TO THE PATIENT'S SHOULDER WAS REPORTED. THE PATIENT DESCRIBED THE SHOCK LIKE A BURN WHICH LASTED FOR HOURS. NO MARKS WERE LEFT ON THE PATIENT'S SKIN FROM THE BELT CLIP BUT PATIENT DESCRIBED RECEIVING A SIGNIFICANT SHOCK LIKE ELECTROCUTING HIM WHEN HE TOUCHED THE TENS UNIT TO REMOVE IT. THE PATIENT SAID HE LATER CHECKED THE CABLES AND SAW NO BARE WIRE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1