MAUDE Adverse Event Report: Neuronetics Inc Neuronetics Inc; TMS

Model Number	v3.8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced a seizure at the very end of his mt determination for tms treatment, during the final refinement of the power needed for treatment.
Additional Manufacturer Narrative
Patient experienced a possible vasovagal/convulsive/syncope episode during the last pulses of the motor threshold determination process for tms treatment.The patient was monitored for 30 minutes with no issues.Patient did not seek further medical assistance/evaluation, nor did they go to the emergency room.The provider initially thought it could have been low blood sugar, but it was acceptable.The treater noted that the provider theorized that the coil placement during the power refinement step (fast mt) may have stimulated the vagus nerve.Patient presented for his daily treatment the next day and did not experience any issues.The patient completed his 15th treatment on (b)(6) 2026.There have been no further issues or concerns.

• Brand Name: Neuronetics Inc
• 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 ; +1(877)600-7555
• MDR Report Key: 50915979
• Report Number: 3004824012-2026-00023
• Device Sequence Number: 17475325
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K233621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: v3.8
• Device Catalogue Number: 81-05315-000
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: Adderall XR 20mg.; Duloxetine 30mg.; Hydroxyzine Pamoate 25 mg.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 199 LB