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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pain (1994); Numbness (2415)

Event Date 03/13/2022

Event Type  Injury  

Event Description

I had a brain mri with contrast, the next day i had a full spine mri, in the machine i started to experience extreme pain in my armpit area, chest and arms.The tech had to keep removing me from the scan and as soon as i went back in the pain would get unmanageable as soon as it started to scan.It has been a week and i am still having chest pain and numbness in my arms.Fda safety report id# (b)(4).

• Brand Name: 3T MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 14188253
• MDR Text Key: 289978579
• Report Number: MW5109280
• Device Sequence Number: 1
• Product Code: LNH
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: IBUPROFEN; TYLENOL ; WELLBUTRIN
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White