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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI SCANNER; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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MRI SCANNER; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Noise, Audible (3273)
Patient Problems Headache (1880); Nausea (1970); Pain (1994); Visual Disturbances (2140); Dizziness (2194)
Event Date 09/05/2018
Event Type  Injury  
Event Description
I had a very painful mri and am now suffering side effects.When i asked tech why i was experiencing uncomfortable heat inside my body (like receiving contrast) and extreme sounds level, he said they decided to change protocols 2-3 weeks ago.I asked if others were complaining as i had and he said yes.He said he didn't agree with changed protocols.When i asked tech if painfully loud and hot mri provided better images, he said the image is the same but we can do them faster and schedule more people per day.I felt dizzy, squinting to focus, nauseous, ear pain, hot and red face, headache and pain in throat, felt drunk as i walked.Six hours later ears are whooshing and sound is painful.I've had to drastically lower volume on radio in car and tv at home.Squinting to focus still.I believe their new protocol is causing harm and putting pts at risk.I did not expect an mri to cause harm, especially since i've had at least 20 in the past with none of these side effects.
 
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Brand Name
MRI SCANNER
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key7859783
MDR Text Key119925747
Report NumberMW5079679
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 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age62 YR
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