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

Model Number	NEUROSTAR TMS THERAPY SYSTEM 3.0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics received a negative comment from the company's social media monitor alleging that tms caused worsening tinnitus.
Additional Manufacturer Narrative
The patient did respond to neuronetics outreach and provided additional information by telephone.The patient has a history of tinnitus and was not wearing the prescribed earplugs during the first week of treatment.After his tinnitus started to worsen he used earplugs for the rest of his treatments.He reports being treated on the right side for three treatments (which is off label protocol) and that also seemed to increase the tinnitus.

• 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: 22922592
• Report Number: 3004824012-2025-00046
• Device Sequence Number: 18699814
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/29/2025

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 SYSTEM 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: 08/04/2025
• Initial Report FDA Received Date: 08/29/2025
• 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: ADDERALL 20MG; BACLOFEN; BUSPIRONE; CLONAZEPAM; CLONIDINE; CYMBALTA; ENBREL; NORTRIPTYLINE; OXYCODONE 1MG UP TO 4X/DAY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White