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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Seizures (2063); Depression (2361)

Event Date 04/24/2018

Event Type  Injury  

Event Description

During a session with neurostar's transcranial magnetic stimulation (tms) to treat depression, my (b)(6) daughter suffered a seizure.The tech said "the threshold was too high." she seized for about a min and a half.She went to the er where she was checked out and released.It has been several days and she is still in full body pain, feels nauseous, and her depression has worsened.Tms is approved in adults and is awaiting approval in adolescents.After the seizure, the provider never called to f/u.We had to call him and he had no answers to our questions.Neither the provider nor neurostar can tell us: how many pts experienced seizures, if any of them continued with treatment or if they all stopped, and what should be done now."the dip" is a common occurrence with tms pts where, around the 3rd week of treatment, they actually feel worse.The way it is described, this is a temporary feeling and will improve as the tms treatments continue.The seizure occurred in the 3rd week, and if she was in that "dip," how will she get out of it since the tms provider said to discontinue treatment.There is no info from the mfr or the tms provider to help us know what to do next.I cannot see how you could approve a device in adolescents when there is no info and no communication after such a major adverse event.I want to know how many pts were in the middle of switching medications for depression while undergoing tms.My daughter was in the midst of a medication switch when we started, and the tms provider said that was ok, that they would just recalibrate the machine once she was on the new medication.The seizure happened after that second re-calibration.This occurred 3 days ago.The physician has not yet contacted neurostar, the mfr.As for any f/u, the tms provider told us to go to my daughter's own dr.I have asked for info to show safety of changing medications during tms treatment, but there does not seem to be any available.Neurostar and the tms provider have abandoned us and have not taken any accountability to what has happened.My daughter was harmed and they are washing their hands.Neurostar says they are "just the mfr" and the tms provider has no info to give us.Pease do not approve this device in adolescents because there is no support or info on what to do after a seizure occurs.We are now in unchartered territory and there is no one to help us.Below where you ask if i've reported the incident.I tried to call neurostar to report it and to get info and was told that only the provider can file a complaint.I am hoping that he does.Neurostar will not answer our questions.Used in office of tms provider.

• Brand Name: NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION
• Manufacturer (Section D): NEURONETICS,INC.
• MDR Report Key: 7475286
• MDR Text Key: 107170305
• Report Number: MW5076921
• Device Sequence Number: 0
• 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: Other
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 15 YR
• Patient Weight: 67