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

Model Number NeuroStar 3.0 US

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

Patient Problems Headache (1880); Skin Discoloration (2074); Tinnitus (2103); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Eye / Vision Problem (4471)

Event Date 06/01/2018

Event Type  Injury  

Event Description

Neuronetics, inc.Received a patient self-reported medwatch form (mw5108910) from fda on 05/03/2022.The patient alleges long-term side effects from three (3) tms treatments he had in 2018.The patient reported prolonged headache and skin discoloration at the treatment site following treatment.He also reported tinnitus and light sensitivity that has persisted for almost four (years).The patient acknowledged that he did not use hearing protection but used personal ear buds.

Manufacturer Narrative

Neuronetics was able to speak with the patient and the tms provider for additional information.Patient received a mapping session and 3 treatments only with neurostar tms.The treating physician confirmed that the "darkened skin" was due to marking the patient's head with a marker.He also did not think the patient's other symptoms were related to tms since he only had 3 treatments and they never got above 50% of 0.81% of the motor threshold.The physician had recommended the patient get an mri but the patient had not followed through.

• Brand Name: NEUROSTAR TMS THERAPY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.; 3222phoenixville pike; malvern PA 19355
• Manufacturer Contact: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 6109814027
• MDR Report Key: 14592588
• MDR Text Key: 293288611
• Report Number: 3004824012-2022-00001
• 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: K161519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NeuroStar 3.0 US
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDICAL MARIJUANA.
• Patient Outcome(s): Disability
• Patient Sex: Male