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

Model Number	NEUROSTAR 3.0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This adverse event is submitted to the agency late as a corrective action since it was determined to be reportable after an audit of the company's complaint database.
Event or Problem Description
Neuronetics received information from a practice that a patient was experiencing worsening tinnitus after starting tms treatment.

• 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 ; 6109814027
• MDR Report Key: 22080058
• Report Number: 3004824012-2025-00022
• Device Sequence Number: 21008363
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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
• Device Model Number: NEUROSTAR 3.0
• Device Catalogue Number: 81-02315-000
• 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: 10/23/2019
• Initial Report FDA Received Date: 05/23/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female