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

Model Number	NEUROSTAR ADVANCED THERAPY SYSTEM 3.6
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics received a report from a practice alleging worsening tinnitus during tms treatment despite wearing hearing protection.
Additional Manufacturer Narrative
The patient is continuing tms and as of the date of this report is on session number 26 of 36 treatments.Her worsening tinnitus has leveled off such that she is able to go about her daily life normally and her depression has improved significantly.

• 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: 22956987
• Report Number: 3004824012-2025-00049
• Device Sequence Number: 15919720
• Product Code: OBP
• UDI-Device Identifier: 00850005944058
• UDI-Public: 00850005944058
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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 ADVANCED THERAPY SYSTEM 3.6
• Device Catalogue Number: 81-03315-000
• 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: 08/06/2025
• Initial Report FDA Received Date: 09/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATIVAN.; BUSPIRONE.; LEXAPRO.; PROPANOLOL.; TRINTELLIX.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White