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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Tinnitus (2103); Depression (2361); Sleep Dysfunction (2517); Suicidal Ideation (4429)

Event Date 06/06/2022

Event Type  Injury  

Event Description

I was doing transcranial magnetic therapy, tms.I started (b)(6) 2022.It has been a horrific experience.I did 15 treatments.The first problem was with the actual doctor office.Dr.(b)(6) was my assigned psychiatrist.She interviewed me with 3 medical students.I filled out numerous forms before my appointment.Scheduled my appointment for first treatment on (b)(6) 2022.It didn't go well because it was too cold for me.The tech wouldn't get my coat out of my car.Had to stop; 2nd, 3rd, 4th treatments were okay.Office ran late.Didn't have a list of my scheduled apps.Lots of other office problems.Had trouble sleeping.Reported to tech.Didn't seem concerned.Couldn't talk to dr.Continued to have problems sleeping.Tried to talk to dr.(b)(6).She was unavailable.Continued to report problems and canceled treatment several times.Started having real problems (b)(6) 2022.Reported to facility.Asked to talk to doctor.Not available.Daily until (b)(6) 2022, tried to get a hold of the doctor.On (b)(6) 2022 called 5 times trying to get a hold of the doctor.Was feeling suicidal.Let staff know.Talked to call center in india and they hung up on me twice.One person lied and said he was the office manager.He wasn't.Finally got a hold of the office and the doctor got on the phone.Had to wait for a call back though.She blew me off basically.Said to take a break; i had already stopped.She was supposed to contact the doctor who prescribed my sleep meds.She didn't, she had promised earlier to get a hold of him because she wanted me to have my sleep med increased, even though she should have looked at my chart and seen i was on the highest dose already.Still have problems due to the treatment.No one is willing to help at (b)(6).I called to let them know that i have problems.They can take a report, a secretary type person, not a medical professional.They won't contact me about the problems.They only take the notes taken and then talk to the provider! said they don't have medical professionals on staff.Again, no one to talk to so i can get help.So frustrating to still have sleep issues depression is worse! tinnitus is much worse.Having rage like never before.Can't explain why this is happening.Medical assistant to dr.(b)(6) called and wanted to talk.She wouldn't let me get off the phone even though i told her multiple times what an awful experience it was for me.Fda safety report id# (b)(4).

Event Description

Additional information received on 18-dec-2023, for mw5111205.Correcting device and manufacturer information.

• Brand Name: BRAINSWAY TMS
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): BRAINSWAY LTD.
• MDR Report Key: 15147009
• MDR Text Key: 297060424
• Report Number: MW5111205
• 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,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: AMBIEN 12.5 MG ; LEVOTHYROXINE 25 MCG; LIOTHYRONINE 35 MCG BID ; LIPOSOMAL C ; MAGNESIUM; POTASSIUM NAC
• Patient Outcome(s): Other; Disability
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White