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

Model Number NEUROSTAR ADVANCED THERAPY V3.0

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Convulsion/Seizure (4406)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Neuronetics received a call from a provider stating that one of their patients had experienced a seizure during their 30th treatment session and was subsequently taken to the emergency room.

Manufacturer Narrative

Provider called to report that one of their patients experienced a seizure lasting 2 minutes during their 30th treatment session and was taken to the er.Patient had tolerated all previous treatment sessions well prior to the event.Patient had been receiving an off label bilateral protocol for treatment.Patient had her mt remapped halfway through the course of treatment, as is standard protocol for the office per provider, and her treatment location shifted as a result.Patient reportedly previously suffered a fall from horseback riding which required her to be taken to the hospital though it is unknown what injury she had suffered as a result.Patient is currently on an antidepressant which could lower her seizure threshold.A week before the event, the patient was sick and took a few days off treatment and reportedly had been sleeping a lot, which may have impacted her seizure threshold.Patient has reportedly recovered well post the event and has not had any sequelae.

• 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: 18411436
• MDR Text Key: 331530067
• Report Number: 3004824012-2023-00027
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: 81-01335-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• 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: FLUOXETINE 90 MG WEEKLY
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic
• Patient Race: White