MAUDE Adverse Event Report: 3T MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number DON'T KNOW

Device Problem Overheating of Device (1437)

Patient Problems Nausea (1970); Vomiting (2144); Dizziness (2194); Malaise (2359)

Event Date 12/24/2020

Event Type  Injury  

Event Description

I had two incidents: on (b)(6) 2020 and (b)(6) 2020 respectively with the 3t mri at touchstone imaging.During my first appointment the 3t magnet was extremely hot on my body (e.G., i was laying in a prone position during both mris).This was my first experience in a 3t mri.Other mri equipment never had resulted in me feeling ill.During the mri i was sick, hot and dizzy.I also felt like i was being moved inside the 3t mri equipment.Once the process was completed, the technician removed me from the 3t mri cylinder.I was weak, dizzy and felt nauseous right there on site.I was sick for the remainder of the day.The next morning, i felt much better.Noteworthy: on 12/16/2020, i had called (b)(6) to make an official report of this incident.I had read an article yesterday while sick about negative side effects from 3t it spoke about medical facilities notifying fda.I am notifying the fda, for an employee/ technician informed me that wasn't their protocol.On (b)(6) 2020 i had to undergo and repeat 3t mri of the same area of my body.My experience this time inside of the 3t mri: was nausea, dizziness, and a tad hot even though this time the air was on inside the 3t mri.A different technician was present.After completion of the imaging.The technician was asking me a few questions.I could barely get off the table and had difficulty standing upright i told the technician i was feeling like i needed to regurgitate and within a few seconds i did.Another employee was present and had assisted me upon my request of scanning my temperature again.I did not have a fever nor was i sick prior to being seen for 3t imaging.I was given some crackers to settle my stomach and i had a bottle of my own water.Also, i had declared aloud that i was never getting inside of a 3t mri ever again.I informed the two employees that i was remaining on their premises outside in my vehicle until i felt well enough to drive home.I remained there for one hour and fifty-five minutes before driving home still queasy and weak.I remained in this state until the next day.Facility name and location: (b)(6).Fda safety report id # (b)(4).

• Brand Name: 3T MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 11100536
• MDR Text Key: 224867652
• Report Number: MW5098607
• Device Sequence Number: 1
• Product Code: LNH
• 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: 12/28/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DON'T KNOW
• Device Catalogue Number: DON'T KNOW
• Device Lot Number: DON'T KNOW
• Was Device Available for Evaluation?: No
• 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: 73