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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Headache (1880)

Event Date 05/01/2021

Event Type  Injury  

Event Description

I get severe headaches at least 4 days per week after getting tms treatment.Fda safety report id # (b)(4).

• Brand Name: NEUROSTAR
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 15094163
• MDR Text Key: 296570865
• Report Number: MW5111076
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• 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: GABAPENTIN; HALDOL; LEXAPRO; ORAL BIRTH CONTROL; WELLBUTRIN; XANAX
• Patient Outcome(s): Disability
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White