BTL EMSELLA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for BTL EMSELLA manufactured by Btl Industries Jsc.

Event Text Entries

[140640625] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085458
• MDR Report Key: 8471094
• Date Received: 2019-03-29
• Date of Report: 2019-03-26
• Date of Event: 2019-01-13
• Date Added to Maude: 2019-04-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BTL EMSELLA
• Generic Name: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE FOR INCONTINENCE
• Product Code: KPI
• Date Received: 2019-03-29
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BTL INDUSTRIES JSC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Deathisabilit	2019-03-29