BEUDAMED
    FDA Adverse Event Other Summary report: N

    RS-TENS

    MDR report key: 2439608 · Received January 20, 2012

    Report

    Report Number
    1644243-2012-00001
    Event Type
    Other
    Date Received
    January 20, 2012
    Date of Event
    November 1, 2011
    Report Date
    November 4, 2011
    Manufacturer
    RS MEDICAL
    Product Code
    GZJ
    PMA / PMN Number
    K050740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE PT'S REPORT INCLUDED OBTAINING AND REVIEWING MEDICAL RECORDS. THE PHYSICIAN'S INITIAL EVAL FORM (DATED (B)(6) 2011, THE DATE THE DEVICE WAS PRESCRIBED) INDICATES 30+ YEAR HISTORY OF CONSTANT BACK PAIN; BILATERAL LOWER EXTREMITY PAIN AND BILATERAL NECK PAIN. THE PHYSICIAN'S FOLLOW-UP CLINIC NOTE (DATED (B)(6) 2011) INDICATES PT HAS 70% IMPROVEMENT WITH HER LOW BACK PAIN FOLLOWING RIGHT AND LEFT L3 - S1 MEDIAL BRANCH NERVE BLOCKS PLUS SI INJECTIONS COMPLETED ON (B)(6) 2011. THERE IS NO MENTION IN THE PHYSICIAN'S NOTE OF SUSPICION OF RELATIONSHIP BETWEEN USE OF THE PRESCRIBED TENS DEVICE AND PT'S CONDITION. THE ACTUAL DEVICE INVOLVED IN THE REPORT WAS EVALUATED. COMPREHENSIVE ELECTRICAL TESTING OF DEVICE OUTPUT WAS PERFORMED. NO FAILURES WERE DETECTED AND THE DEVICE OPERATED ACCORDING TO SPECS.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE IS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) DESIGNED TO DELIVER ELECTRICAL SIGNALS THROUGH ELECTRODES PLACED ON THE SKIN. PT REPORTED ON (B)(6) 2011 THAT SHE TURNED THE DEVICE ON AND THEN EXPERIENCED PAIN IN HER RIGHT GROIN THAT RADIATED INTO HER CALF. PT FURTHER REPORTED THAT NOW HER ANKLE HURTS. PT STATED THAT SHE HAD EXPERIENCED THIS PAIN BEFORE BUT NOT IN 2 YEARS. PT DID NOT REPORT SEEKING IMMEDIATE MEDICAL ATTENTION FOR THE FOREGOING SYMPTOMS. DURING FOLLOW-UP WITH PT ON (B)(6) 2011, PT REPORTED THAT SHE HAD SPOKEN WITH HER DOCTOR WHO TOLD HER THAT DEVICE WAS RESPONSIBLE FOR PAIN AND DOCTOR ADVISED TO DISCONTINUE DEVICE USE. DURING FOLLOW-UP WITH PT ON (B)(6) 2011, PT STATED THAT SHE HAD BEEN HOSPITALIZED FOR 3 DAYS COMPLAINING OF MUSCLE SPASMS AND PAIN. NOTE: EXACT DATE OF HOSPITALIZATION IS UNK; REPORTED TIME SERIES PER PT'S STATEMENTS INDICATES DATE IS BETWEEN (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization