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

Model Number NEUROSTAR ADVANCED THERAPY V1.0

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

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Nausea (1970); Dizziness (2194); Depression (2361); Lethargy (2560)

Event Date 01/29/2024

Event Type  Injury  

Event Description

A caregiver called into neuronetics to report that after their daughter received a full course of tms, her depressive symptoms worsened significantly and is now bedridden.When speaking with the patient's provider, the patient began to reportedly experience her symptoms following tms including "dizziness, nausea, sensitivity to sound, facial pain, 'zapping' at site of scalp around where coil [was], migraines, memory problems, worsening depression, and has been in bed x2 weeks".

Manufacturer Narrative

Neuronetics received a call from a caregiver that reported that after their daughter received tms, her daughter (the patient) experienced a significant worsening of her depression and has been bedridden.The caregiver reportedly voiced their concerns to the patient's provider but was not satisfied with the provider's response to her concerns.The caregiver stated that the patient has had depression since she was 16 and has been drinking alcohol from "an early age".Per the caregiver, the patient entered rehab for her alcohol use disorder earlier in 2023 and since leaving rehab her depression has gotten worse.Neuronetics contacted the patient's provider for further information.Per the provider, the patient began to reportedly experience her symptoms following her course of tms.Provider noted that patient did experience headaches during tms but they reportedly had gotten worse following tms.The provider noted that these symptoms were of an unclear etiology and "would be unusual for tms to cause symptoms after tms completed".The provider reported that the patient discontinued her viibryd during treatment herself which could have resulted in the patient experiencing a "serotonin withdrawal" but the caregiver states that the patient did not have any medication changes during treatment.The provider recommended that the patient see a neurologist but at this time the patient has not had a chance to see one.Based on the confounding information provided, it cannot be determined whether the tms treatment caused or contributed to the patient's condition.The company is reporting out of an abundance of caution.

• 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: 18836091
• MDR Text Key: 336866503
• Report Number: 3004824012-2024-00005
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083538
• 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
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY V1.0
• Device Catalogue Number: 81-60000-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• 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
• Treatment: ACAMPROSATE 666 MG TID; BUPROPRION 150 MG QD; GABAPENTIN 600 MG BID; VIIBRYD 40 MG QD
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White