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U.S. Department of Health and Human Services

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

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MRI SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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.
 
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Brand NameMRI
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key6686006
MDR Text Key79237328
Report NumberMW5070781
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received07/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/02/2017 Patient Sequence Number: 1
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