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

Model Number NEUROSTAR ADVANCED THERAPY V3.6

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Convulsion/Seizure (4406)

Event Date 08/07/2023

Event Type  Injury  

Event Description

Neuronetics received a call from a provider reporting that one of their patients experienced a seizure during their 9th treatment session and was taken to the emergency room.

Manufacturer Narrative

Tms provider reported to neuronetics that a patient was experiencing eye pain/discomfort and hand/arm movement during treatment.The treater reportedly attempted to alleviate the patient's discomfort and hand/arm movement in a manner which is not recommended by neuronetics.After making the adjustments, the patient "arched his back" and allegedly had a seizure.The seizure allegedly lasted 3-4 minutes and the patient was taken to the er.Patient has reportedly experienced "convulsions" due to past medications though he has not been diagnosed with a seizure disorder.Patient is currently on several medications that may influence the seizure threshold (pristiq, depakote, seroquel, fioricet).It was noted that the patient has been having difficulty obtaining several of his medications and may not have been taking them consistently which may have also influenced the seizure threshold.Patient has stopped treatment and is scheduled to see a neurologist for follow up.

• 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: 17631922
• MDR Text Key: 322061496
• Report Number: 3004824012-2023-00020
• Device Sequence Number: 1
• Product Code: OBP
• UDI-Device Identifier: 00850005944058
• UDI-Public: 00850005944058
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY V3.6
• Device Catalogue Number: 81-03315-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• 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: DEPAKOTE; FIORICET; PRISTIQ 25 MG 1T QD; SEROQUEL 100 MG 1T HS
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White