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 03/15/2024

Event Type  Injury  

Manufacturer Narrative

Provider contacted neurometrics to report that one of their patients experienced a seizure during their 8th treatment session.Ems was called and the patient was taken to the er, however patient left before being evaluated due to long wait time.Patient has a previous history of seizures and has been documented with a diagnosis of generalized convulsive epilepsy by a previous provider but this condition has reportedly been resolved.Patient is currently on several medications that could impact his seizure threshold, including zoloft, ziprasidone, clomipramine, and ativan.Patient also has autism which is a risk factor for seizures.Patient has currently stopped tms and has an upcoming appointment with a neurologist for evaluation.Due to the patient's medical history and concomitant medications, it is unclear if tms contributed to the seizure.

Event Description

Neurometrics received a call from a provider reporting one of their patients experienced a seizure during his 8th treatment session.Ems was called following the event and patient was taken to the er.

Manufacturer Narrative

Neuronetics received further information related to mdr 3004824012-2024-00011 from the provider's office clarifying the device the patient was treated with when the event occurred.The office has several devices and the previous mdr submitted contained the incorrect device information.This report contains the correct device information.

• 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): .; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: anna gorbunov ; 3222 phoenixville pike; malvern, PA 19355 ; 6016404202
• MDR Report Key: 19089478
• MDR Text Key: 339940022
• Report Number: 3004824012-2024-00011
• 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,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• 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: 03/18/2024
• 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: ATIVAN 4 MG A DAY; CLOMIPRAMINE 200 MG EVENING; GUANFACINE 2MG IN AM AND 3MG IN PM; LYRICA 25MG QID AND 5X/DAY EVERY OTHER DAY; MEMANTINE 5 MG MORNING AND 10 MG AFTERNOON; N-ACETYLCYSTEINE 600 MG BID; ZIPRASIDONE 40 MG BID WITH FOOD; ZOLOFT 50 MG IN EVENING
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 200 KG
• Patient Race: White