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

Device Problem Insufficient Information (3190)

Patient Problems Convulsion/Seizure (4406); Suicidal Ideation (4429)

Event Type  Injury  

Manufacturer Narrative

Neuronetics was notified of a patient comment made on one of neuronetics' posts by a social media monitor.The social media monitor reported that the patient posted the same comment multiple times in multiple places to the point where it could be considered possible spam activity.The comments posted allege that the patient had received tms therapy several years ago and following her treatment, she began to experience seizures, worsening of her depression/anxiety, being newly diagnosed with ocd and bipolar disorder, and had attempted suicide.Neuronetics has made several attempts to contact the patient for further information regarding the alleged complaints, but they have all been unsuccessful.Due to the lack of information and inability to fully investigate, it is not possible to determine treatment timelines, medical history, concomitant medications, or confirm whether the alleged complaints were collaborated by medical specialists.Neuronetics is submitting a report based on the severity of the alleged complaints though it is unknown whether the patient was treated with neurostar.

Event Description

Neuronetics was informed of a facebook comment that was posted by a patient which claimed that after receiving tms her depression and anxiety has worsened, she now has ocd and bipolar disorder, has been having seizures, and had attempted suicide.

• 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 ; 6106404202
• MDR Report Key: 17998367
• MDR Text Key: 326422520
• Report Number: 3004824012-2023-00025
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Female