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

Model Number	NEUROSTAR 3.8
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Emotional Changes (1831)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics received a medwatch (mw5169286) from fda in which a patient alleges he experienced a hypomanic episode after his 20th tms session at which time his treatment was stopped.
Additional Manufacturer Narrative
The patient provided his contact information in the medwatch report and therefore neuronetics was able to obtain additional information including the practice where he was treated.The practice confirmed that they were concerned the patient was experiencing symptoms of hypomania which could reflect a bipolar variant.Bipolar disorder is currently not a cleared indication for use and hypomania is a rare but serious potential side effect from tms treatment in patients with such disorders.

• 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: 22088384
• Report Number: 3004824012-2025-00026
• Device Sequence Number: 18109598
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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 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: 04/30/2025
• Initial Report FDA Received Date: 05/27/2025
• 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: 68 YR
• Patient Sex: Male