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

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Fatigue (1849); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Brain Injury (2219); Anxiety (2328); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Suicidal Ideation (4429)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Neuronetics received a medwatch from a patient's wife alleging the above reported adverse events after the patient received a total of 46 treatment sessions.The patient later called the fda back with further information on the alleged adverse events.No contact information was provided to conduct a thorough investigation and therefore neuronetics cannot confirm the details of the alleged events or confirm that a neurostar device was used to treat the patient.

Event Description

Neuronetics received a medwatch from a patient's wife alleging that, after receiving a total of 46 treatment sessions, her husband experienced the following symptoms: jaw pain, extreme anxiety, pacing, severe insomnia, "an out of mind feeling", hospitalization for suicidal ideation and hypomania, severe mdd, chronic diarrhea, headache, cognitive impairment, severe brain injury, confusion, hair loss, and fatigue.

• 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: 19177100
• MDR Text Key: 340998809
• Report Number: 3004824012-2024-00012
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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: 03/28/2024
• 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
• Patient Outcome(s): Other