MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR ADVANCED THERAPY; TMS

Model Number	V.3.8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Anxiety (2328); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On the day of the event, the individual said she did not feel comfortable driving herself home.Text messages from the individual to provider over the two days following the treatment said she was feeling little better and agreed that could possibly be a migraine.The volunteer was out of work for about 3 weeks, had medication changes, and additional meds prescribed to treat her migraines.The individual returned to work the week of 3/17/26 for full days.She says the migraines are better but still gets headaches and is sensitive to noise and light.She says that she is now experiencing terrible brain fog, and her overall mental health issues are worse.There may be other factors involved as well since the individual was under a lot of stress in the weeks prior to the event, has a history of migraines and possible other medical concerns.She has had an mri and is waiting for results.
Event or Problem Description
A provider's nurse was a training volunteer for doing a tms mt.The individual also received a single itbs (touchstar theta burst) treatment at 35-50% of the determined power following the mt.About an hour later she experienced a headache, dizziness, and felt like she was having an anxiety attack.She missed two days of work initially but ended up missing about 3 weeks.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TMS
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: nadine lievenbruck ; 3222 phoenixville pike; malvern, PA 19355 ; 8776007555
• MDR Report Key: 24675643
• Report Number: 3004824012-2026-00012
• Device Sequence Number: 10360391
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K233621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: V.3.8
• Device Catalogue Number: 81-05315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: METOPROLOL 100MG (FOR PVCS); UBRELVY (FOR MIGRAINE RESCUE)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White