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 and concomitant medications.The practice indicated that the patient was very stressed, sleep deprived and had increased caffeine intake, all of which may have contributed to lower her seizure threshold.
Event or Problem Description
Neuronetics, inc.Received an email from a customer on (b)(6) 2022 indicating that a patient had a seizure during her 13th treatment session that day.The seizure lasted about 35 seconds; post ictal lasted about 2 to 3 minutes.Ems was called but the patient declined transport to the er.The practice confirmed that the patient sought evaluation by a neurologist and that the patient condition has returned to normal with no observed sequelae.The practice also confirmed that the patient was continuing 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: 16162729
• Report Number: 3004824012-2023-00001
• Device Sequence Number: 7005907
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• 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: Physician
• 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: FLOXETINE 60MG DAILY (INCREASED FROM 40-60MG); KLONOPIN 0.5MG 2X DAILY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White