MAUDE Adverse Event Report: MAGVENTURE A/S MAGVENTURE TMS THERAPY; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Tinnitus (2103); Dizziness (2194); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 07/19/2022

Event Type  Injury  

Event Description

A reporter called to submit a report about the adverse events he experienced from tms therapy.He said after the therapy he had the following symptoms: tinnitus, dizziness, disorientation, pressure in his head, insomnia.

• Brand Name: MAGVENTURE TMS THERAPY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): MAGVENTURE A/S
• MDR Report Key: 15085974
• MDR Text Key: 296511492
• Report Number: MW5111068
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 68 KG