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

Model Number	NS 3.7
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation included a review of the patient's medical history, concomitant medications, and sequence of events associated with the seizure.Movement was exhibited in patient's right hand prior to seizure onset.The treater moved the coil forward until hand movement ceased, however, due to patient discomfort at the new site, coil was returned to its original position.The patient's hand continued to exhibit movement the day of the seizure.Subsequent neurological workup, including ct scan findings, were normal.Lab workup found the patient was dehydrated; iv fluids were administered.Dehydration carries a known seizure risk.Other predisposing factors include prescribed medications which have a seizure risk.Patient is currently doing well with no lasting sequelae but has stopped tms.Patient continues to be seen by a neurologist for assessment.
Event or Problem Description
A practice contacted neuronetics to report a patient had a seizure during her 4th tms treatment.

• Brand Name: NEUROSTAR 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: 16162849
• Report Number: 3004824012-2023-00002
• Device Sequence Number: 7396702
• 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): 01/13/2023

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: NS 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: 12/14/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CLONAZEPAM (1MG); DULOXETINE HCL (20 MG); MIRTAZAPINE (30MG); PROPRANOLOL HCL (10 MG); SPIRONOLACTONE (25 MG)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White