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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Diarrhea (1811); Headache (1880); Muscle Spasm(s) (1966); Pain (1994); Sepsis (2067); Weakness (2145); Stenosis (2263); Lethargy (2560)

Event Date 01/13/2019

Event Type  Injury  

Event Description

Product: btl emsella, (b)(4), trial 28 min emsella session (b)(6) 2019 for stress and urge urinary incontinence.Subsequent 28 minute emsella sessions (b)(6) 2019.Urosepsis and autoimmune flare requiring hospitalization (b)(6) 2019.Possibly a little less urinary leaking after 1 session, but after (b)(6) 2019 session, urinary leaking worsen.Thought possibly related to bladder medication myrbetriq was working against what emsella was doing so myrbetriq stopped (b)(6) 2019.Parallel to patient complaining of more urinary leaking, she also complained of more headaches since starting emsella.She has chronic pain from multi-level cervical spinal stenosis and severe muscle spasm of her upper back, neck, and head.The muscle spasms and chronic headaches were more intense but she also complained of pain located at her temples and front of head hurt after starting emsella.Patient saw her rheumatologist (b)(6) 2019, who was very astute to pick up on the fact that patient said her headache caused pain in her bilateral temporal area.Rheumatologist expressed concern for possible temporal arteritis and ordered blood tests to evaluate for this.Esr and crp were very high.Patient got very ill (b)(6) 2019, with sudden severe episode of explosive diarrhea and extreme lethargy and weakness, feeling ¿very bad¿ to where only wanted to lay down and sleep, not answering phone or eat.Patient (lives alone in a senior retirement community) managed to call family early the next morning to say she was feeling bad.Family took her to emergency room where she was diagnosed with urosepsis (with enterococcus) and admitted to the hospital.During the hospitalization, oral steroids were started for possible temporal arteritis pending temporal artery biopsy results.Biopsy did not show vascular inflammation, but steroids seemed to be necessary to help quell the autoimmune flare.It has been slow going for patient to recover.Did not tolerate weaning off steroids, so longer course for 3 months prescribed.Also still having controlled urinary leaking.

• Brand Name: BTL EMSELLA
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE FOR INCONTINENCE
• Manufacturer (Section D): BTL INDUSTRIES JSC
• MDR Report Key: 8471094
• MDR Text Key: 140640625
• Report Number: MW5085458
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 86 YR
• Patient Weight: 49