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

Model Number NEUROSTAR ADVANCED THERAPY 3.0

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

Patient Problems Head Injury (1879); Hearing Impairment (1881); Nausea (1970); Vertigo (2134); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

The tms provider could not be reached to provide additional information and therefore a full investigation coud not be completed.

Event Description

Neuronetics received a patient reported medwatch (mw5115632) from fda alleging that the patient had adverse reactions from 20-30 tms therapy treatments including headaches, sleep interuptions, scalp irritation, vertigo, nausea and eardrum twitching that affects hearing.

• 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: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 6109814027
• MDR Report Key: 16771069
• MDR Text Key: 313599104
• Report Number: 3004824012-2023-00009
• 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: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY 3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BUSPIRONE.; EXCEDRINE FOR HEADACHES.; PRISTIQ.; TOPIRAMATE (PRESCRIBED FOR VERTIGO).
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Hispanic
• Patient Race: White