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

Model Number	V.3.8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tinnitus (2103); Partial Hearing Loss (4472)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient had not worn earplugs until she tried using them on the 10th treatment.Patient experienced a tinnitus episode on the 11th treatment so will not receive any further treatments until seen by an ent.Patient denied having any tinnitus prior to these episodes.She reports a slight subjective worsening of hearing while at work.However, the patient has not followed up to schedule an appointment with the ent.Provider has no clear cause to attribute the symptoms.Per patient, tinnitus and subjective hearing loss have not affected her regular routine but is bothersome.
Event or Problem Description
Practice reported a female patient started to experience new onset bilateral tinnitus on (b)(6) 2026 while at work and again 2x that evening.It occurred for the first time during treatment on (b)(6) 2026.

• Brand Name: NEUROSTAR ADVANCED THERAPY SYSTEM
• Common Device Name: TMS
• Manufacturer (Section D): NEURONETICS, INC; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC.; 3222phoenixville pike; malvern PA 19355
• Manufacturer Contact: nadine lievenbruck ; 3222 phoenixville pike; malvern, PA 19355 ; 8776007555
• MDR Report Key: 24339966
• Report Number: 3004824012-2026-00005
• Device Sequence Number: 20026377
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K233621
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

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.3.8
• Device Catalogue Number: 81-05315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/13/2026
• 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: FLUOXETINE 40 MG PO Q DAY.; METOCLOPRAMINDE 10MG PO Q DAY.; MODAFINIL 200MG PO Q DAY FOR WAKEFULNESS.; WELLBUTRIN LX 300 MG PO Q DAY.; XANAX 0.25 MG PO Q DAY PRN (RARELY TAKEN).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 75 KG