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

Model Number NEUROSTAR ADVANCED THERAPY V3.0

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

Patient Problem Convulsion/Seizure (4406)

Event Date 10/12/2023

Event Type  Injury  

Event Description

Provider contaced neuronetics to report a patient who had experienced a seizure during their 17th treatment session.

Manufacturer Narrative

Neuronetics was contacted by a provider that reported one of their patients had experienced a seizure about 10 minutes into their 17th treatment session.Patient's vitals were monitored at the provider's office and patient's spouse was called following the event.Patient was taken back home by spouse.Provider followed up with the patient the next day following the event who reported that she was "still stiff/hurting" last night but did not have a headache.Patient had requested provider refer her to neurology.The referred neurologist requested that the patient go to the er to faciliate access to an earlier appointment.Er notes that at the time of visit: patient had not continued with tms, has not experienced any more seizures, and expresses that she would like to continue with tms.Per er notes, patient's exam was normal and neurology has cleared the patient to return for tms with seizure precautions in the office.Despite being cleared by neurology to continue with treatment, patient has decided not to conitnue at this time.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION
• 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 ; 6106404202
• MDR Report Key: 18525087
• MDR Text Key: 333024879
• Report Number: 3004824012-2024-00002
• 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: K220127
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY V3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• 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: ALBUTEROL 90 MCG/ACTUATION 2 PUFFS BY MOUTH.; AMITRIPTYLINE 150 MG AT BEDTIME.; METOPROLOL SUCCINATE ER 50 MG DAILY.; VITAMIN B COMPLEX.; VITAMIN D2.
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White