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	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics, inc.Received a call from a company representative that one of his accounts had a patient who had a seizure during his 10th tms treatment session.The seizure lasted only 2-3 minutes but the patient was taken to the emergency room and had a ct scan which was normal.The patient was discharged the same day and has been doing well with no visible lasting issues.
Additional Manufacturer Narrative
The investigation included a review of the patient's medical history and concomitant medications.The patient was diagnosed with asperger's syndrome which may have lowered his seizure threshold.Seizure disorders and epilepsy are frequently reported comorbidities in individuals with autism spectrum disorder which includes the signs and symptoms that were once part of an asperger's diagnosis.Additionally, two of the medications the patient was taking (clomid and amphetamine-dextroamphetamine) could also potentially lower his seizure threshold.

• 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: 16035931
• Report Number: 3004824012-2022-00025
• Device Sequence Number: 15322254
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/22/2022

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: 11/23/2022
• Initial Report FDA Received Date: 12/22/2022
• 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: AMPHETAMINE-DEXTROAMPHETAMINE 10MG BID (HOLDING); ANASTROZOLE 1MG; ARMOUR THYROID 90MG IN AM; CLOMID 50MG 1/2 TABLET ONCE WEEKLY; LISINOPRIL 40MG; VERAPAMIL 40MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic