BEUDAMED
    FDA Adverse Event Other Summary report: N

    RS TENS PLUS

    MDR report key: 1736337 · Received June 18, 2010

    Report

    Report Number
    1644243-2010-00005
    Event Type
    Other
    Date Received
    June 18, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    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

    PT RECEIVED LETTER CONCERNING CORRECTIVE ACTION ON RS-FBG CONDUCTIVE GARMENT AND REVISED OPERATION MANUAL WITH WARNINGS ON STIMULATION OF THE NECK AND TELEPHONED CUSTOMER SERVICE TO INQUIRE IF SHORTNESS OF BREATH AND TIGHTENED NECK MUSCLES COULD OCCUR WITH ELECTRICAL STIMULATION WITH CONVENTIONAL ELECTRODE PADS ALONE. PT WAS GOING TO CONSULT WITH PHYSICIAN (DR. (B)(6)). NO FURTHER INFORMATION HAS BEEN RECEIVED POST-PHYSICIAN CONSULTATION. NO SPECIFIC DEVICE EVALUATION HAS OCCURRED BASED ON THIS REPORT. MDR FILED - (B)(4) 2010.

    Description of Event or Problem · 1

    PT REPORTED USING TENS STIMULATOR WITH 2" ROUND ELECTRODE PADS, PLACING THEM ABOVE HER SHOULDERS ON THE BACK OF HER NECK; PT TOOK A TREATMENT ON HER NECK ABOUT 3-4 DAYS PRIOR AND EXPERIENCED SHORTNESS OF BREATH AND REAL TIGHTNESS IN HER NECK MUSCLES. PT SAYS SHE ALSO FELT NAUSEOUS; IN THE PAST SHE HAS TAKEN TREATMENTS ON HER NECK AND SHE NEVER EXPERIENCED THOSE SIDE EFFECTS WHEN SHE DID. LAST TREATMENT SHE TOOK ON HER NECK WAS MONTHS AGO, PT HAS NEVER EXPERIENCED THESE SYMPTOMS BEFORE IN HER LIFE. RIGHT NOW PT IS STILL EXPERIENCING SHORTNESS OF BREATH AND STIFFNESS IN HER NECK.

    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 74 YR Other REPORTED EVENT).| RS-FBG CONDUCTIVE GARMENT (NOT USED DURING