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

Model Number	NEUROSTAR ADVANCED THERAPY V3.6
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics received a call from a provider reporting that one of their patients experienced a seizure during their 9th treatment session and was taken to the emergency room.
Additional Manufacturer Narrative
Tms provider reported to neuronetics that a patient was experiencing eye pain/discomfort and hand/arm movement during treatment.The treater reportedly attempted to alleviate the patient's discomfort and hand/arm movement in a manner which is not recommended by neuronetics.After making the adjustments, the patient "arched his back" and allegedly had a seizure.The seizure allegedly lasted 3-4 minutes and the patient was taken to the er.Patient has reportedly experienced "convulsions" due to past medications though he has not been diagnosed with a seizure disorder.Patient is currently on several medications that may influence the seizure threshold (pristiq, depakote, seroquel, fioricet).It was noted that the patient has been having difficulty obtaining several of his medications and may not have been taking them consistently which may have also influenced the seizure threshold.Patient has stopped treatment and is scheduled to see a neurologist for follow up.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: anna gorbunov ; 3222 phoenixville pike; malvern, PA 19355
• MDR Report Key: 17631922
• Report Number: 3004824012-2023-00020
• Device Sequence Number: 7618153
• Product Code: OBP
• UDI-Device Identifier: 00850005944058
• UDI-Public: 00850005944058
• 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): 08/28/2023

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 ADVANCED THERAPY V3.6
• Device Catalogue Number: 81-03315-000
• 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: 08/09/2023
• Initial Report FDA Received Date: 08/28/2023
• 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: DEPAKOTE; FIORICET; PRISTIQ 25 MG 1T QD; SEROQUEL 100 MG 1T HS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White