MAUDE Adverse Event Report: NEURONETICS, INC. NEURUOSTAR ADVANCED THERAPY; TRANSCRANIAL MAGNETIC STIMULATOR

Model Number	NEUROSTAR 3.7
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The provider changed the mdd protocol parameters since the patient was not responding to treatment of 10hz/4sec stim/26sec interval/3000 pulses/120% smt.The altered parameter was 20hx/4sec stim/26sec interval/3000 pulses/100% smt.Notes stated that the patient was treated at 120% smt which was above the altered protocl.This revised protocol and subsequent treatment was well above the ninds seizure guidelines of no more than 1 sec of stimulation time at 20hz at the 100%smt.
Event or Problem Description
Tms provider contacted neuronetics to inform that a patient had a seizure during their 21st treatment.Seizure was estimated to last approximately 4 minutes.911 was called and emt transported patient to the hospital.The patient fully recovered from the seizure and was released from the hospital.

• Brand Name: NEURUOSTAR ADVANCED THERAPY
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 6106404202
• MDR Report Key: 16482495
• Report Number: 3004824012-2023-00005
• Device Sequence Number: 15387932
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201158
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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 3.7
• Device Catalogue Number: 81-04315-000
• 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: 02/02/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (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: ESTRADIOL 2MG; GUANFACINE 1MG; ONDANSETRON 4MG; PROGESTERONE 100MG; SILDENAFIL 25MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Male