MAUDE Adverse Event Report: BTL INDUSTRIES JSC EMSELLA ELECTROMAGNETIC STIMULATOR; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Patient Problems Abdominal Pain (1685); Fatigue (1849); Nausea (1970); Undesired Nerve Stimulation (1980); Sleep Dysfunction (2517); Gastrointestinal Regurgitation (4477); Urinary Incontinence (4572)

Event Date 04/29/2023

Event Type  Injury  

Event Description

Patient problems: diffuse severe abdominal pain.Severe almost constant nausea.Feeling of esophageal regurgitation.General body weakness.Restlessness.Insomnia.Intolerance of supine rest position.The patient (b)(6) dob (b)(6) 1962.Was having episodes of urinary incontinence while exercising and decided to make use of the emsella electromagnetic stimulator for urinary incontinence.In the facility she was recommended to take six 30-minute sessions.The emsella electromagnetic stimulator is used in urinary incontinence treatment in women as well as in men.For men the procedure has been applied for treatment of erectile dysfunction.Recommendations of its use for these conditions are predicated in its effect on stimulating the pelvic musculature.In effect patients receiving this treatment report significant muscular involuntary contractions that are described as pleasurable.Patients are generally recommended 4 to 6 sessions according to response to treatment.There is no apparent consideration as to the patient's body mass or to their basic metabolic rate.The present patient ((b)(6) is a slender person 5 feet 3 inches tall and at the time of the procedure was 115 lbs.In weight.After the procedure and largely because of her gastrointestinal symptoms she now weighs 104 to 107 pounds.The symptoms described interfere severely with food intake.The beneficial effects of the treatment have been amply described almost with universal hype and no side effects other than beneficial side effects are emphasized.Even though the effect on pelvic musculature is amply described, no effect in the gastrointestinal musculature has been studied or reported.I am a pathologist and i believe that the electro magnetic stimulation received with the emsella instrument affects both pelvic and gastrointestinal musculature and that the stimulatory effects on the intestinal musculature can cause severe gastrointestinal symptoms as in the case of (b)(6).I further believe that the effects may be mass related, and that dosing of length and frequency of the procedures should be based on body mass in addition to factors such evaluation of response before additional procedures are recommended.I urge the fda to ask the manufacturer and the vendors of this popular procedure to more closely investigate negative side effects of the procedure.

• Brand Name: EMSELLA ELECTROMAGNETIC STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): BTL INDUSTRIES JSC
• MDR Report Key: 17670063
• MDR Text Key: 322695644
• Report Number: MW5145110
• Device Sequence Number: 1
• Product Code: KPI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR