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

Model Number	NEUROSTAR 3.8
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Ambulation or Postural Difficulties (2544)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The medwatch report included contact information enabling neuronetics to follow up with the patient's mother and the provider.Other than mild, transient headache, the reported symptoms of dizziness and ambulation/postural difficulties are not typical side effects of tms.The patient's provider noted that the patient has had side effects from most medications and that there could be other outside factors impacting the patient.The patient discontinued treatment after the 19th session.The tms provider referred the patient to a pediatric neurologist who suggested she may have a functional disorder and scheduled her for an mri in may 2025.The patient's mother reported she has improved, with the exception of the weakness in her legs, since tms treatment stopped.There is no evidence to determine if the patient's health complaints are due to tms treatment or another health issue.
Event or Problem Description
Neuronetics received medwatch (mw) 5163619 from fda via email on january 6, 2025.The mw was reported by the mother of a female patient who alleges headaches, dizziness, and unsteadiness/leg weakness after receiving 19 neurostar advanced therapy tms treatments.About a week after the symptoms appeared the patient fell and was taken to the er for testing.

• Brand Name: NEUROSTAR ADVANCED THERAPY SYSTEM
• 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: 21221682
• Report Number: 3004824012-2025-00002
• Device Sequence Number: 3326629
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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 3.8
• Device Catalogue Number: 81-05315-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/23/2025
• 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: DESVENLAFAZINE 50MG, BID; TYLENOL; VISTARIL 25MG, QD; VITAMINS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White