BEUDAMED
    FDA Adverse Event Other Summary report: N

    RS-TENS PLUS

    MDR report key: 1677079 · Received May 4, 2010

    Report

    Report Number
    1644243-2010-00002
    Event Type
    Other
    Date Received
    May 4, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 6, 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

    THE RS-TENS PLUS LABELING CONTRAINDICATES USE IN PATIENTS WITH IMPLANTED PULSE GENERATORS. RS MEDICAL CUSTOMER SERVICE RECOMMENDED RETURN OF THE TENS STIMULATOR AND ACCESSORY CONDUCTIVE GARMENT. WHEN THE DEVICES HAVE BEEN RETURNED, ELECTRICAL PERFORMANCE TESTING OF THE STIMULATOR WILL BE PERFORMED AND FOLLOW-UP INFORMATION WILL BE SUPPLEMENTED TO THE MDR.

    Description of Event or Problem · 1

    PATIENT WAS PRESCRIBED A TENS STIMULATOR AND RS-LBL LOW BACK CONDUCTIVE GARMENT FOR TREATING LOW BACK PAIN. PATIENT ALSO HAD A VAGUS NERVE STIMULATOR IMPLANTED ON CHEST. PATIENT STATED THEY USED THE TENS STIMULATOR ONCE WITHOUT THE CONDUCTIVE GARMENT AND IT TURNED OFF THE IMPLANTED PULSE GENERATOR. PHYSICIAN NEEDED TO REACTIVATE THE IMPLANTED PULSE GENERATOR (IPG) VIA PROGRAMMING AND BEGIN PATIENT'S VAGUS NERVE STIMULATION TREATMENTS OVER. NO OTHER ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    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 58 YR Other (LUMBAR BRACE).| RS-LBL LOW BACK CONDUCTIVE GARMENT:S/N (B)(4)| - PT STATED THAT GARMENT WAS NOT USED.| PT ALSO HAS AN RS-LFS LUMBAR FUNCTIONAL SYSTEM