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

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994); Burning Sensation (2146)

Event Date 06/29/2017

Event Type  Injury  

Event Description

I went to get an mri at (b)(6) radiology in (b)(6) of my right foot in order to see if i have nerve damage as a result of a workman's comp injury that occurred at work on (b)(6) 2017 at (b)(6).I put my bag and phone in a provided locker.I was not given a gown, and i was placed on the machine with my hands and my hips.As i went into the machine and it started making the loud sound, i could feel the nerve in my right foot start to squirm (it felt very snakelike) and then i experienced slight burning, and it was getting worse.It felt like someone had lit each nerve on fire or had an electrical wire attached to each nerve.The pain traveled up my leg to the upper body including and mostly the left arm, my heart, the left shoulder, the left side of my head and i could not hold the pose anymore as tears from the excruciating pain was running through my body.It took the tech over a minute to notice that there was a problem.He did ask if i was alright.I said, "no".I told him that i left like i was being tortured in the chamber.He then dismissively said, "well, it has never happened here." i was offered no assistance or referral.They were closing, so i was left there in pain.As i drove home which is about 1 mile away, my chest started burning more, squeezing, i had trouble breathing.I finally got home, parked, and could not make it up the stairs.The pain was getting worse.So my neighbor saw me and called 911.They came, did an ekg and took other visits, and they decided that i needed to go to the hospital.So they admitted me to cedars-sinai.I feel like i got burned and electrocuted.And now after reading other people's stories, my scenario was similar.The machine did looked old.And the tech was not thorough.I felt rushed and he looked irritated and responded to me in a dismissive and rude manner.

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 6686006
• MDR Text Key: 79237328
• Report Number: MW5070781
• 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: 07/02/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 53 YR
• Patient Weight: 105