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

Device Problems Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problems Diarrhea (1811); Emotional Changes (1831); Pain (1994); Anxiety (2328); Depression (2361); Irritability (2421); Sleep Dysfunction (2517); Suicidal Ideation (4429)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Patient¿s wife called to report on behalf of her husband (b)(6) regarding a very serious adverse reaction to tms (transmagnetic stimulation) treatment he started receiving in (b)(6) of 2023.Reporter stated that her husband underwent 36 sessions of tms for treatment resistant depression.Reporter stated that while undergoing the treatments, her husband experienced jaw pain, extreme anxiety, state of mania, pacing, insomnia and experienced an ¿out of mind¿ feeling.Reporter stated the tms clinic recommended 10 additional treatments, off label, to help with the extreme anxiety, mania, and insomnia, however the patient ended up being hospitalized in (b)(6) of 2023 for suicidal ideation and hypo-mania.Reporter stated her husband¿s main symptoms were mania, severe depression, severe anxiety, severe insomnia, and chronic diarrhea.Reporter stated her husband is under the care of a psychiatrist and gi doctor and is currently in an intense out-patient program.Reporter stated her husband still suffers from suicidal ideation that comes and goes, anxiety, low mood, depression, agitation, and frustration.Reporter stated before tms he was functioning and able to work, but since the tms treatments he isn't functioning well, can¿t work and has been told it¿s almost like he¿s suffered a traumatic brain injury.Reporter stated there is progress but it¿s very slow.Reporter stated her husband is now on antidepressants and mood stabilizers, but his condition is still not well controlled.

Event Description

Additional information received from reporter on 27-mar-2024, for mw5153120.Reporter calling to add manufacturer and other information.Reporter states he received "forty" tms treatments on the left side of his brain in "(b)(6) 2023", as well as "ten" treatments on the right side of his brain in "(b)(6) 2023".Reporter states the treatments performed on the right side of his brain, particularly, were "off-label".Reporter states he is part of a facebook support group called "victims of tms" and he states that numerous members of this group have experienced extremely negative side effects after receiving tms treatment, and that some have even committed suicide.Reporter states that when searching for information online about tms, the negative side effects of treatment are "never mentioned".Reporter states "i almost killed myself last summer" and states that he now has agoraphobia, several food insensitivities/food allergies, irritable bowel syndrome, and states that the side effects of tms treatment "have been a nightmare for me".Reporter states he cannot believe that the fda has approved these devices for treatment, and states "tms is a torture device".Reporter states that his mental health was "more stable" prior to having tms treatments.

Event Description

Additional information received from a reporter on 27-mar-2024, for a report #mw5153120.Reporter called to add the treatment center name and address.(b)(6).

Event Description

Additional information received from reporter on 15-apr-2024, for a report number mw5153120.The reporter said he has new and add'l symptoms, as follows: anxiety increased, new, headache, depression increased and new, neck and back pain, suicidal ideation, terrible insomnia, manic new, cognitive impairment, fatigue, short term memory loss, severe brain injury, nerve damage, dry eye, vertigo, increased sensitivity to light and sound, ibs, irritability, weight loss, disorientation, confusion, hair loss and hair fell out.

• Brand Name: NEUROSTAR TMS
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 18977431
• MDR Text Key: 338562909
• Report Number: MW5153120
• 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,Followup,Followup
• Report Date: 04/15/2024

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?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/27/2024; 03/28/2024; 04/16/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Sex: Male