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

Model Number	NEUROSTAR TMS THERAPY SYTEM 3..0
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hyporesponsive to stimuli (2683)
Date of Event	03/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The person who posted the alleged adverse event did not respond to a request to contact neuronetics' customer service to obtain additional information although they did provide the name of the practice where he was treated.Neuronetics confirmed the practice was a neurostar provider and that he was treated in (b)(6) 2014.The provider stated that the patient didn't mention the loss of smell until (b)(6) 2015, 5 months after tms treatment.The provider also noted that the patient was being weaned off of cymbalta during this time.There are reported side effects with cymbalta and smell impairment.Loss of sense smell is not a known side effect of tms but neuronetics is submitting out of an abundance of caution given the allegation of a potential serious adverse event.
Event or Problem Description
Neuronetics was made aware of negative comments, on a neurostar post, by the company's social media monitor including one that alleged that tms treatment caused anosmia (sense of smell loss).

• Brand Name: NEUROSTAR
• 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: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 8776007555
• MDR Report Key: 22353255
• Report Number: 3004824012-2025-00037
• Device Sequence Number: 20814523
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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 TMS THERAPY SYTEM 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: 05/29/2025
• Initial Report FDA Received Date: 06/30/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male