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

Model Number NEUROSTAR ADVANCED THERAPY V 3.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Convulsion/Seizure (4406)

Event Date 03/05/2024

Event Type  Injury  

Event Description

Provider called neuronetics to report that one of their patients experienced a seizure during her 5th treatment session.An ambulance was called after the event occurred and the patient was taken to the er.

Manufacturer Narrative

Neuronetics received a call from a provider reporting one of their patients experienced a seizure during their 5th treatment sessions.When speaking with the provider regarding the event, the provider themselves does not believe that the patient experienced an "actual seizure".The provider believes that the patient may have suffered a "pseudo-seizure" as the patient reportedly: was alert and oriented following the event, there was no post-ictal stage, did not loose consciousness, and was responsive.The provider believes that this may have been caused by the increase in treatment power.The provider reported that the patient has a smaller head and that the increase in intensity may have resulted in the patient's motor strip being stimulated.After the event occurred, the patient was sent to the er as a precaution and to be checked out.The patient reportedly did not have a full work up done at the er and was not seen by any specialist while there.Since the event, the patient has returned to tms treatment with an altered protocol and has not had any issues since.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Type of Device: 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: 18964378
• MDR Text Key: 338429875
• Report Number: 3004824012-2024-00009
• Device Sequence Number: 1
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY V 3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SERTRALINE 200 MG PO QD; VRAYLAR 3 MG PO QD; XANAX 0.5 MG PO PRN ANXIETY ATTACKS
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female