BEUDAMED
    FDA Adverse Event Other Summary report: N

    RS-FBG FULL BACK CONDUCTIVE GARMENT

    MDR report key: 1823784 · Received August 26, 2010

    Report

    Report Number
    1644243-2010-00009
    Event Type
    Other
    Date Received
    August 26, 2010
    Date of Event
    January 1, 2007
    Report Date
    July 29, 2010
    Manufacturer
    RS MEDICAL
    Product Code
    GZJ
    PMA / PMN Number
    K090951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CONTACTED RS MEDICAL BASED ON RECEIPT OF A (B)(4) 2010 RS-FBG FIELD CORRECTION LETTER AND UPDATED RS-FBG OPERATION MANUAL WHICH STATES POTENTIAL FOR BREATHING DIFFICULTY AND HEART RATE CHANGES IF DEVICE USED FOR STIMULATION OF THE NECK. "WARNING: DO NOT APPLY STIMULATION OVER THE NECK. SEVERE SPASM OF THE MUSCLES MAY OCCUR AND THE CONTRACTIONS MAY BE STRONG ENOUGH TO CLOSE THE AIRWAY OR CAUSE DIFFICULTY IN BREATHING. STIMULATION OVER THE NECK COULD ALSO HAVE ADVERSE EFFECTS ON THE HEART RHYTHM OR BLOOD PRESSURE." ACCOMPANYING RS-4I STIMULATOR OPERATION MANUAL DID STATE "SEVERE SPASM OF THE LARYNGEAL AND PHARYNGEAL MUSCLES MAY OCCUR WHEN PADS ARE POSITIONED OVER THE NECK OR MOUTH. THE CONTRACTIONS MAY BE STRONG ENOUGH TO CLOSE THE AIRWAY OR CAUSE DIFFICULTY IN BREATHING." ADDITIONALLY "CAUTION SHOULD BE USED IN TRANSTHORACIC APPLICATION OF ELECTRICAL STIMULATION. THE INTRODUCTION OF ELECTRICAL CURRENT INTO THE HEART MAY CAUSE ARRHYTHMIAS" PRESCRIBED ELECTRODE LOCATIONS FOR THE PATIENT INCLUDED THE UPPER TRAPEZIUS MUSCLE AREA. THE RS-FBG CONDUCTIVE GARMENT WAS REPORTEDLY DISPOSED OF BY THE PATIENT AFTER THE REPORTED EVENT. THE RS-4I STIMULATOR HAS NOT BEEN RETURNED TO RS MEDICAL FOR EVALUATION AND IS BEING USED BY THE PATIENT FOR TREATMENTS WITHOUT FURTHER REPORTED ADVERSE EVENTS. MDR FILED - (B)(4) 2010.

    Description of Event or Problem · 1

    PATIENT RECOUNTING AN EPISODE THAT HAPPENED SOME 3 YEARS PRIOR. PATIENT WAS USING RS-FBG FULL BACK CONDUCTIVE GARMENT AND RS-4I SEQUENTIAL STIMULATOR AND EXPERIENCED CHEST PAIN AND WENT TO HOSPITAL. PHYSICIAN INDICATED THAT THE STIMULATION TRIGGERED SOMETHING IN PATIENT'S HEART. THE PATIENT WAS COMFORTABLE DURING THE TREATMENT BUT THEN BEGAN NOTICING THE PAIN NOT FAR INTO A TREATMENT. ELECTRODE PADS WERE LOCATED BY THE RS-FBG GARMENT ON THE PATIENT'S UPPER BACK AREA. PATIENT DISCARDED THE RS-FBG GARMENT AND IS CONTINUING TO TAKE STIMULATION TREATMENTS USING 2" ROUND ELECTRODES IN SAME AREA POSITIONED MANUALLY. PATIENT IS DOING WELL AND NOT HAVING ANY RECURRENCE OF PROBLEMS TAKING STIMULATION TREATMENTS WITH MANUALLY POSITIONED ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RS-FBG FULL BACK CONDUCTIVE GARMENT NONE GZJ RS MEDICAL RS-FBG

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other GARMENT| PRESCRIBED WITH THE RS-FBG FULL BACK CONDUCTIVE| RS-4I SEQUENTIAL STIMULATOR ((B)(4)) WAS