MAUDE Adverse Event Report: NEURONETICS, INC. TMS NEUROSTAR; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Therapeutic Response, Decreased (2271); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517)

Event Date 09/02/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 i began tms.My doctor led me to believe there were no significant side effects and that it may be possible to reduce or even eliminate my use of anti-depressants.He said it wasn't covered by insurance yet but was expected to be by (b)(6) so we could do it now and he would bill insurance when it was covered.The first day after treatment i was flat.No emotion.Felt like i was outside of my body.That friday, i cried the entire time during treatment bc it made my depression extremely worse.My depression was manageable before tms.I was only on two different meds.The reason i decided to try it is because my doctor said there would be a good chance i wouldn't have to take any meds after treatment.During each session i told the technician that i was feeling worse.My husband and i sent emails to the doctor informing him of my condition.We were told to just keep doing the treatments.On (b)(6) 2014 i was admitted into the psych ward in the hospital.I had only been once before in 2006 due to a major traumatic event.Within the next 9 months, i was hospitalized a total of 7 times.I suffered from mania, depression, anxiety, paranoia, insomnia, psychosis, self-harm, suicidal ideation, memory loss, and about hurting others.I was unable to work from 9/9/2014 - 7/18/2016 due to severe depression and anxiety and no will to live.I had never experienced this before.I lost my job of 19 years with the same company.It impacted every aspect of me and my family's life.My memory has gotten some better in the last year but i still don't remember a lot of things.I have tinnitus constantly.Mri shows that i have advanced atrophy of my frontal temporal lobe for my age and now the other part of my brain is hanging over the part that atrophied.My migraines have increased.I have phantosmia.Terrible insomnia and sleep disturbances.I used to have no problems sleeping.Sciatica.I don't remember watching movies, how to spell, even don't recognize people that obviously know me.It nearly killed me and it ruined my life.It ruined my family's lives.I beg of the fda to please investigate these claims.I have found others who have experienced similar side effects.My family and friends are more than willing to give a first hand account of what happened.I was and still am traumatized by the experience.I cringe and have to change the channel when i hear my ex doctor on tv promoting tms in commercials.I hate driving by the hospital where i had to go all of those times during those 9 months.I have been stereotyped and discriminated against by medical professionals thinking i'm just mentally ill because there are no warnings for these symptoms by the fda.Fortunately, i have a wonderful, strong loving family to support me and help me through it.Mental health wise, i'm better than i ever was before.General health wise, i'm worse than i was before.I absolutely 100% welcome any contact from the fda to discuss further.I hear the same stories over and over about people feeling the same way during treatment but told not to stop.To keep going.What happen to the hippocratic oath? fda safety report id# (b)(4).

• Brand Name: TMS NEUROSTAR
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.
• MDR Report Key: 11285471
• MDR Text Key: 230474317
• Report Number: MW5099238
• Device Sequence Number: 1
• Product Code: OBP
• 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: 02/03/2021

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: 02/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADVIL (AS NEEDED); BENADRYL 50MG AT NIGHT TO SLEEP ; CLONAZEPAM .5MG AT NIGHT TO SLEEP ; DEXILANT 60MG/ 1X DAY ; EMGALITY 1X MONTH ; FISH OIL ; LAMOTRIGINE 150MG/ 1.5 TABLETS/ 1X ; LINZESS 290MCG/ 1X ; MAGNESIUM 1X DAY FOR MIGRAINE ; MELATONIN 10MG AT NIGHT TO SLEEP ; MONTELUKAST SODIUM 10MG/ 1X DAY ; PROMETHAZINE HCL 25MG AS NEEDED FOR MIGRAINE ; PROPRANOLOL 10MG 2X DAY ; RESTASIS 2X DAY ; SILVER CENTRUM (WOMEN'S) 1X DAYS ; SIMVISTATIN 20MG 1X DAY ; TYLENOL (AS NEEDED)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 44 YR