BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT SMART RELIEF TENS BACK PAIN THERAPY

    MDR report key: 6629035 · Received June 9, 2017

    Report

    Report Number
    1022556-2017-00003
    Event Type
    Injury
    Date Received
    June 9, 2017
    Report Date
    May 30, 2017
    Manufacturer
    CHATTEM
    Product Code
    NUH
    PMA / PMN Number
    K131159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED FROM THE PATIENT ON (B)(6) 2017. THIS CASE INVOLVES FEMALE PATIENT OF UNKNOWN AGE, WHO EXPERIENCED ATRIAL FIBRILLATION, AFTER STARTING TREATMENT WITH SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS THERAPY). MEDICAL HISTORY INCLUDED: ATRIAL FIBRILLATION. PAST DRUGS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH SMART RELIEF TENS THERAPY AT AN UNSPECIFIED FREQUENCY (LOT/BATCH NUMBER AND EXPIRY DATE: UNKNOWN) FOR BACK PAIN. THE PATIENT STATED SHE HAD A FIB (ATRIAL FIBRILLATION), AND HAD IT BEFORE USING THE SMART RELIEF. SHE STATED SHE HAD A QUICK BOUT OF A-FIB (ONSET DATE: UNKNOWN) ABOUT 40 MINUTES AFTER USING THE TENS, BUT SHE SAID IT WAS NORMAL FOR HER TO GET IT SPORADICALLY. SHE WANTED TO BE SURE IT WAS NOT CAUSED BY THE SMART RELIEF. ACTION TAKEN: UNKNOWN CORRECTIVE TREATMENT: NOT REPORTED OUTCOME: UNKNOWN SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6) 2017: THIS CASE CONCERNS A FEMALE PATIENT OF UNKNOWN AGE WHO EXPERIENCED ATRIAL FIBRILLATION AFTER THE USE OF THE DEVICE; SMART RELIEF TENS THERAPY USED FOR BACK PAIN. THE CAUSAL ROLE OF SUSPECT DEVICE CANNOT BE DENIED FOR THE REPORTED EVENT; HOWEVER THIS CASE LACKS INFORMATION REGARDING THE CONDITION OF THE SKIN AT THE CONTACT AREA PRIOR TO APPLYING THE DEVICE LEADS (E.G., WET, DRY, OPEN WOUNDS) AND PATIENT'S MEDICAL HISTORY OF ATRIAL FIBRILLATION FOR UNKNOWN DURATION IS A CONFOUNDER FOR THE EVENT.

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED FROM THE PATIENT ON 30- MAY-2017. THIS CASE INVOLVES FEMALE PATIENT OF UNKNOWN AGE, WHO EXPERIENCED ATRIAL FIBRILLATION, AFTER STARTING TREATMENT WITH SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS BACK PAIN THERAPY). MEDICAL HISTORY INCLUDED: ATRIAL FIBRILLATION. PAST DRUGS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH SMART RELIEF TENS THERAPY AT AN UNSPECIFIED FREQUENCY (LOT/BATCH NUMBER AND EXPIRY DATE: UNKNOWN) FOR BACK PAIN. THE PATIENT STATED SHE HAD A FIB (ATRIAL FIBRILLATION), AND HAD IT BEFORE USING THE SMART RELIEF. SHE STATED SHE HAD A QUICK BOUT OF A-FIB (ONSET DATE: UNKNOWN) ABOUT 40 MINUTES AFTER USING THE TENS, BUT SHE SAID IT WAS NORMAL FOR HER TO GET IT SPORADICALLY. SHE WANTED TO BE SURE IT WAS NOT CAUSED BY THE SMART RELIEF. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN. QA REVIEW WAS PERFORMED AND INVESTIGATION FINDINGS WERE REPORTED AS 'ALL RETAINS ARE EXAMINED FOR CORRECT PACKAGING, SEAL, MISSING COMPONENTS, WORKING CONTROL UNIT, LEGIBILITY OF LOT NUMBERS /EXPIRATION DATE, CORRECT LABEL AND FOREIGN MATTER. NO ANOMALIES WERE FOUND THAT COULD CONTRIBUTE TO THIS COMPLAINT'. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT ADDITIONAL INFORMATION WAS RECEIVED FROM THE QUALITY DEPARTMENT ON 30-MAY-2017. QA REVIEW FINDINGS WERE ADDED. TEXT AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 30-05-2017: THE NEW FOLLOW UP INFORMATION RECEIVED DOES NOT CHANGE THE PREVIOUS CASE ASSESSMENT. SANOFI COMPANY COMMENT DATED 02-05-2017: THIS CASE CONCERNS A FEMALE PATIENT OF UNKNOWN AGE WHO EXPERIENCED ATRIAL FIBRILLATION AFTER THE USE OF THE DEVICE; SMART RELIEF TENS THERAPY USED FOR BACK PAIN. THE CAUSAL ROLE OF SUSPECT DEVICE CANNOT BE DENIED FOR THE REPORTED EVENT; HOWEVER THIS CASE LACKS INFORMATION REGARDING THE CONDITION OF THE SKIN AT THE CONTACT AREA PRIOR TO APPLYING THE DEVICE LEADS (E.G., WET, DRY, OPEN WOUNDS) AND PATIENT'S MEDICAL HISTORY OF ATRIAL FIBRILLATION FOR UNKNOWN DURATION IS A CONFOUNDER FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412661 ICY HOT SMART RELIEF TENS BACK PAIN THERAPY TRANSCUTANEOUS NERVE STIMULATOR NUH CHATTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other