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

Model Number	V.3.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The provider reported that a patient was experiencing new bilateral tinnitus.The patient said they were hearing a high frequency sound in both ears.This does not interfere with their daily routine or are able work.Patient said that it varies in pitch and frequency but may be a little better since pausing tms treatment.Patient would like to continue with tms but provider wants to wait until they have a complete work up with the second ent.Patient has seen an urgent care provider and one ent so far and both stated that the findings were all normal or not informative as to the reason for the new tinnitus.
Event or Problem Description
The provider reported that a patient on their 12th ocd/mdd tms session was experiencing bilateral high frequency tinnitus that had been unremitting for several days.
Additional Manufacturer Narrative
Ent report was obtained on (b)(6) 2026.This report indicates that the patient has normal to moderate sensorineural hearing loss in the right ear and normal sloping to a mild to moderate sensorineural hearing loss in the left ear.Provider feels that tinnitus is more likely related to high-frequency sensorineural hearing loss than from tms.The patient's employment involves a potentially loud work environment on a regular basis.Patient was cleared by the ent to continue tms if they choose to do so.Patient was seeing benefit for their depression and ocd when they originally stopped treatment.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• 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: nadine lievenbruck ; 3222 phoenixville pike; malvern, PA 19355 ; 8776007555
• MDR Report Key: 24378731
• Report Number: 3004824012-2026-00006
• Device Sequence Number: 13387980
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: V.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: 01/23/2026
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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: ABILIFY 2MG STOPPED THEN RESTARTED END (B)(6) 2026; ABILIFY 2MG STOPPED THEN RESTARTED END (B)(6)2026; LEVOTHYROXINE 150MG DAILY; LEVOTHYROXINE 150MG DAILY; PROZAC 40MG INCREASED TO 60MG IN (B)(6) 2026; PROZAC 40MG INCREASED TO 60MG IN (B)(6) 2026; XANAX 0.25MG; XANAX 0.25MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White