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

Model Number	V.3.0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Headache (1880)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reported having 70 migraines per month compared to 2-3 per month prior to tms.The patient sought care at the er due to the migraines and has been given an anti-convulsant medication which seems to be helping more than anything else yet.However, the patient did not have any complaints during treatment or for the past 6 months.Whenever the practice has spoken with the patient (since she called with the complaint), the patient has a positive happy affect (mood) when speaking to her.This doesn't match what she is telling them.The patient was open with the treater during her course of treatment that she was constantly searching the internet for side effects from tms and tends to have attention seeking behaviors.The patient alleges that she lost her job due to the increase in migraines, however, the patient has a history of losing jobs (reasons unknown).
Event or Problem Description
The patient notified the tms provider's office that they have been experiencing worsening migraines since ending tms treatment 6 months ago.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TMS
• Manufacturer (Section D): NEURONETICS, INC; 3222 phoenixville pile; 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: 24038320
• Report Number: 3004824012-2026-00002
• Device Sequence Number: 9260095
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161519
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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.3.0
• Device Catalogue Number: 81-01335-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (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: DRISODOL 1.25 INJECTION MONTHLY (VIT D).; KEPPRA 250.; LAMICTAL 150 DAILY.; NORFLEX 100MG BID PRN.; NURTEC 75 EVERY OTHER DAY.; TENEX.; TORADOL 10 MG BID PRN.; ZOFRAN 80 PRN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic