MAUDE Adverse Event Report: NEURONETICS INC. TMS - TRANSCRANIAL MAGNETIC STIMULATION NEUROSTAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Twitching (2172)

Event Date 03/16/2020

Event Type  Injury  

Event Description

I was prescribed the procedure tms transcranial magnetic stimulation approved by fda and started with the first session.I was having my eye twitching and i complained to the technician and (b)(6) told me to do a deep breath that it would pass.After a week kept getting worse and i talked to dr.(b)(6) (psychiatrist) and she said she would talk with neurostar specialist to see what could be done.I called neurostar customer service and they said they didn't know about it and i should contact the doctor.They said the doctor should had called them and resolved but never did.I asked the office for the neurostar specialist to call me and explain if my eye twitching would be permanent and he never called me.I told the office i would stop the treatment until they would tell me what to do and if that twitching would be permanent.As today (april 07) the office sent an email telling me they will not treat anymore and i should see another office that would have the other kind of machine that would not trigger my eye twitching.Of course, after they had said it would not be permanent.I felt very uncomfortable and so far the company neurostar will not call me back and the doctor dumped me without any help.I told them i would check on them to let them know if my eye got better.But has been 1 week and my eye still not better (i can sleep now) but it is all day twitching.That side effect was not disclosed in any time for me.Fda safety report id # (b)(4).

• Brand Name: TMS - TRANSCRANIAL MAGNETIC STIMULATION NEUROSTAR
• Type of Device: TRANSCRANIAL MAGNETIC
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 9948095
• MDR Text Key: 187575216
• Report Number: MW5094093
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 41 YR
• Patient Weight: 73