MAUDE Adverse Event Report: TMS; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Tinnitus (2103); Twitching (2172); Dizziness (2194); Dysphasia (2195); Sneezing (2251); Anxiety (2328); Sleep Dysfunction (2517); Cognitive Changes (2551); Eye Pain (4467); Unspecified Eye / Vision Problem (4471)

Event Date 10/10/2021

Event Type  Injury  

Event Description

After tms treatment i suffered a short memory loss, eye pain, headaches, light sensitivity, felt like there was a bright light bulb in my eye which affected my vision, concentration problems ( still ongoing), speech problems eye twitching (ongoing) nonstop anxiety i have no good days anymore, everyday i'm miserable.Insomnia, lightheaded, tinnitus, trouble gathering my thoughts, having allergy like symptoms since like runny and stuffy nose, sneezing (ongoing).Neurostim.Fda safety report id # (b)(4).

• Brand Name: TMS
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• MDR Report Key: 14789193
• MDR Text Key: 294935584
• Report Number: MW5110475
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Patient Sequence Number: 1
• Treatment: B COMPLEX; LORAZEPAM; METOPROLOL; NEXIUM
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White