MAUDE Adverse Event Report: NEURONETICS INC. NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION (TMS) SYSTEM; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Pain (1994); Tinnitus (2103); Suicidal Ideation (4429)

Event Date 08/26/2022

Event Type  Injury  

Event Description

During my tms treatment with the neurostar tms machine, i experienced severe pain and suicidal ideation.I stopped treatment and while the suicidal ideation stopped, the headaches, jaw pain, and tinnitus are still ongoing.Fda safety report id # (b)(4).

• Brand Name: NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION (TMS) SYSTEM
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 15348490
• MDR Text Key: 299169784
• Report Number: MW5111850
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ATIVAN ; KYLEENA IUD; VYVANSE
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White