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

Model Number	NEUROSTAR 3.0
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Emotional Changes (1831); Headache (1880); Pain (1994); Twitching (2172); Anxiety (2328); Irritability (2421); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The medwatch report included the patient name and contact information enabling neuronetics to follow up with the patient and the provider.Patient's phq-9 depression score improved after the 36 treatments.The provider could not corroborate all the allegations made by the patient.Patient record included discomfort and numbness in the right forearm which went away.There is no evidence to determine if the patient's health complaints are due to tms treatment or a progression of other mental health issues (severe gad, bipolar ii and/or borderline personality disorder) which are not currently cleared for tms treatment.
Event or Problem Description
Neuronetics received medwatch (mw) 5162644 from fda via email on december 9, 2024.In the mw a female patient alleges emotional changes after receiving neurostar tms treatment.These emotional changes include paranoia, anxiety, and feeling of annoyance and anger all the time.She also alleges feeling of "bugs crawling on her skin", constant headaches and painful right hand and forearm.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATION
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS INC; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 6109814027
• MDR Report Key: 21081607
• Report Number: 3004824012-2025-00001
• Device Sequence Number: 8333834
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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: NEUROSTAR 3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/06/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUVELITY; B12; BENADRYL; CYMBALTA; IRON; METFORMIN; TOPROL XL; TYLENOL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White