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	Emotional Changes (1831)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient received 3 mdd treatments then had ocd treatment added.After the patient's 3rd ocd treatment, the patient began to express many complaints (listed total of 63).Both the practice and the patient attributed the complaints to his pre-existing type of ocd in which he fixates on things he cannot see that are happening inside his body.For example, he started to have an intrusive fear that the tms was going to hurt his brain.When office manager of the practice spoke with him on the phone on (b)(6) 2026, he was still employed and participating in travel for work.Complaint has not resolved.On (b)(6) 2026, nni requested a status from the patient who stated that he thinks his complaints also revolve around the mdd treatment.In addition, the patient experienced panic attacks which he had not had since 2014.He has not noted having any further panic attacks.He told the office manager that he went back to the office where he had received previous full course of tms for mdd.According to the patient, he continued with mdd treatment at another practice but did not add ocd.
Event or Problem Description
Patient emailed the practice and nni directly but separately regarding a very long list of complaints that he felt are related to tms treatment.The patient listed a large number of issues which when reviewed showed a worsening of ocd and possibly mdd symptoms which appear to have started after having ocd added to the mdd treatment.
Additional Manufacturer Narrative
Related to medwatch # mw5187174.

• 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: 24903600
• Report Number: 3004824012-2026-00014
• Device Sequence Number: 9827814
• Product Code: QCI
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/04/2026
• 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: FINASTERIDE 1 MG; FINASTERIDE 1 MG; METHYLCOBALAMIN 150 MG / WK; METHYLCOBALAMIN 150 MG / WK; NIZORAL 2% SHAMPOO; NIZORAL 2% SHAMPOO; TRINTELLIX 10 MG; TRINTELLIX 10 MG; VITAMIN B COMPLEX-HYDROXOCOBAL SOL. 0.5 ML INJ/WK; VITAMIN B COMPLEX-HYDROXOCOBAL SOL. 0.5 ML INJ/WK; WELLBUTRIN XL 300 MG; WELLBUTRIN XL 300 MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White