MAUDE Adverse Event Report: TONICA ELEKTRONIK A/S MAGVENTURE MAGPRO TRANSCRANIAL MAGNETIC STIMULATION; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/09/2021

Event Type  Injury  

Event Description

I was at the (b)(6) receiving my 28th treatment on one of the three tms devices.There was an unlicensed and uncertified technician that was assigned to me for that appointment and she did not know how to control the device appropriately.As a result, i involuntarily bit my tongue.At this point, i requested that the treatment to be stopped and i let the staff know, including the office manager, (b)(6) who stated that they were: "discharging me from service" and not at all interested in my injury.The attending physician who was supposed to be there, was at one of their other locations.Furthermore, as a medical professional, i specifically asked whether the "treatments" were "electrical" in nature, and the attending physician and technician assured me that "there were none" and that it was just "magnetic treatment".If that were true, why would the treatment potentiate the nerves? also, i was concerned with memory and my ability to play chess as i play in a league.The physician and technician both assured me that my memory would not be affected and it would improve my chess game, if anything.These two statements also proved to be false.I have lost significant ranking in my chess league.Fda safety report id # (b)(4).

• Brand Name: MAGVENTURE MAGPRO TRANSCRANIAL MAGNETIC STIMULATION
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): TONICA ELEKTRONIK A/S
• MDR Report Key: 12032181
• MDR Text Key: 257435427
• Report Number: MW5101972
• Device Sequence Number: 1
• Product Code: OBP
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 113