BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT SMART RELIEF TENS THERAPY

    MDR report key: 3842668 · Received May 16, 2014

    Report

    Report Number
    1022556-2014-59210
    Event Type
    Injury
    Date Received
    May 16, 2014
    Report Date
    April 30, 2014
    Manufacturer
    CHATTEM, INC.
    Product Code
    NUH
    PMA / PMN Number
    K131159
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI AVENTIS COMPANY COMMENT (B)(4) 2014: ALTHOUGH THE ROLE OF TENS DEVICE CANNOT BE DENIED FOR THE EVENT OF LOSS OF CONTROL OF LEGS, HOWEVER, SUFFICIENT (INFO IS REQUIRED REGARDING PT'S CONCURRENT CONDITION, CONCOMITANT MEDICATIONS FOR A COMPREHENSIVE ASSESSMENT.

    Description of Event or Problem · 1

    INITIAL INFO REGARDING UNSOLICITED SERIOUS DEVICE CASE FROM UNITED STATES WAS RECEIVED FROM A PT ON (B)(6) 2014. THIS CASE INVOLVES A (B)(6) MALE PT WHO EXPERIENCED LOST MUSCLE CONTROL OF LEGS, EXPERIENCED SWITCH, LEGS AND ARMS STARTED FLAILING ON THEIR OWN AND WHOLE BODY STARTED TO ITCH, FEW MINUTES AFTER STARTING SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS THERAPY STARTER KIT BACK). THE PT ALSO EXPERIENCED MUSCLE SPASMS AND FELT LIKE HIT BY A MACK TRUCK, UNK DURATION AFTER STARTING THE THERAPY. CONCOMITANT MEDICATIONS AND RELEVANT MEDICAL HISTORY: NOT PROVIDED. ON AN UNK DATE, THE PT STARTED SMART RELIEF TENS THERAPY (DOSE, ROUTE, FORM, FREQUENCY, LOT/BATCH NUMBER AND EXPIRATION DATE WAS NOT PROVIDED) FOR SORE ELBOW. PT USED THE DEVICE SORE ELBOW FOR APPROX 3 MINUTES. ROUGHLY AN HOUR AFTER USAGE, PARTS OF PT'S BODY STARTED TO ITCH INTENSELY FOLLOWED BY ITCHING IN WHOLE BODY. MINUTES LATER, DIFFERENT PARTS OF THIS BODY STARTED TO SWITCH UNCONTROLLABLY. WITHIN 10 MINUTES, HIS LEGS AND ARMS STARTED FLAILING ON THEIR OWN AND HE LOST MUSCLE CONTROL OF LEGS AND ARMS. PT WENT TO AN ER AND STAYED THERE APPROX FOR 2 HOURS. THEY WERE ABLE TO CONTROL THE VIOLENT FLAILING BUT PT STILL HAD MINOR MUSCLE SPASMS (ONSET DATE WAS UNK). PT FELT THAT HE WAS HIT BY A MACK TRUCK (ONSET DATE WAS UNK). PT WAS POSITIVE THAT THIS DEVICE TRIGGERED THIS EPISODE AS NOTHING IN HIS DIET OR ROUTINE HAD CHANGED. ACTION TAKEN: UNK. INFO ON CORRECTIVE TREATMENT WAS NOT PROVIDED. OUTCOME WAS UNK FOR ALL THE EVENTS. SERIOUSNESS CRITERIA: THE EVENT OF LOST MUSCLE CONTROL OF LEGS WAS MEDICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293137 ICY HOT SMART RELIEF TENS THERAPY TRANSCUTANEOUS NERVE STIMULATOR NUH CHATTEM, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other PREV MEDS = UNK| CON MEDS = UNK