MAUDE Adverse Event Report: BRAINSWAY LTD. BRAINSWAY DEEP TMS MACHINE; TRANSCRANIAL MAGNETIC STIMULATOR

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

Patient Problems Pulmonary Embolism (1498); Erythema (1840); Pain (1994); Swelling (2091); Thrombosis (2100)

Event Date 02/12/2019

Event Type  Injury  

Event Description

I received transcranial magnetic stimulation on (b)(6).I immediately had shoulder pain after treatment.The pain was in my opposite shoulder of treatment (left), where twitching and pulling occurs of the muscles.I was putting pain ointment on the area the morning of (b)(6), and realized my left arm was very swollen and red.I went to urgent care where i was diagnosed with a deep vein thrombosis (dvt-blood clot) in the axillary vein of my left arm.A week later i was still having pain and had a pulmonary embolism in the chest area of where the muscle twitching occurs.I am on a high strength of the machine because i am currently taking 50 mg of trokendi.I think there needs to be a warning on the machine to limit the strength of the machine as this is dangerous.

• Brand Name: BRAINSWAY DEEP TMS MACHINE
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): BRAINSWAY LTD.
• MDR Report Key: 8392423
• MDR Text Key: 137984496
• Report Number: MW5084658
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• 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; Life Threatening
• Patient Age: 37 YR
• Patient Weight: 154