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U.S. Department of Health and Human Services

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

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MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Pain (1994); Swelling (2091); Visual Impairment (2138); Burning Sensation (2146)
Event Date 08/23/2019
Event Type  Injury  
Event Description
Dr ordered 3 mri's of shoulder joints and neck area.I was called for pre test info and asked if i had any artificial or metal devices-joints, stents, prosthetics etc.I said yes, i have bilateral titanium jaw joints and plates done in (b)(6) 2018 and (b)(6) 2018.She then asked if i was claustrophobic, i said no.She asked if i had an mri before i said yes, many but don't think i've had any since these joints were put in unless your facility did one that i don't remember.She said not at their facility.Records show only a ct done there.She set the appt and said to be at the facility by 6 pm for a 6:20 appt, and to bring my id and medical ins cards.I arrived and given a personal info sheet to review and sign for consent and was told to keep the chart and give it to the tech when taken back for the scans.I reviewed the sheet and found two major errors.First across from questions asking if i had any prosthetics etc and it was pre checked no.Second across from question asking if i had any metal implants or joints etc, and again it was checked no.I corrected both errors and hand wrote in that i had bilateral titanium joints and plates in my face and then signed the document.I went up to the front desk to talk to someone about the discrepancy but no one was available.An hour later when i still hadn't been called back, i went back to the desk looking for someone to speak with.A person emptying trash containers came in and i asked if there was anyone still working at this desk and if she knew where they were.She said maybe he was in the bathroom? i said i doubt that after all this time.She found him and i asked how much longer this was going to take.He said they had been behind since the afternoon.I asked why they didn't bother to call? a few mins later i was called back and gave my chart to the tech.I was told to remove all metal from the waist up including my bra and put on a grown.When i was taken into the mri room, he asked what kind of music i liked and gave me ear plugs.I told him that i may have trouble putting in the ear plugs because of my implants especially on the left side.Several times when he had me move down or over during placement on the table for the three scans - i told him certain movements were hard for me with the implants and that i needed his help / arm etc.I also told him several times that the two shoulder scans were extremely hard to get through.He asked if i could hear the music and i said barely and only a little a couple of times because the pounding was hurting my head.He reiterated that i had the bulb and if i needed to stop to just squeeze the bulb.The final scan was the neck and it was the most horrific pain imaginable.My face was pounding in stabbing pain and the nerves on the sides of my face and jaws were burning and i had flashes of white light in my right eye.I didn't squeeze the bulb because i didn't want to have to start the scan over or redo it later.When it was over, i couldn't get up off the table without his help.He helped me up and asked if i was dizzy and i said yes and in pain.I had trouble getting dressed afterward because the pain was still throbbing and burning.I kept seeing flashes of while light in my eyes.I waited in the parking lot until i felt it was safer to drive but i still was having trouble with my vision when light hit them.Even the lights on my car dash caused my eyes to burn.I took back roads home to avoid lighted areas.Saturday my face was swollen on both sides of my jawline down to my mouth with tremendous pain.Most of the night i was awake with pain.Sunday i got up with more swelling and now jawline bruising.Although i had limited oral opening before the scans i now have none.I've used heat and ice to get the swelling down and arnicare to reduce the pain from bruising, however the internal pain is still very uncomfortable and i lost what limited oral opening i had.Fda safety report id# (b)(4).
 
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Brand Name
MRI MACHINE
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key8940887
MDR Text Key156390717
Report NumberMW5089408
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 08/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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) Other; Disability;
Patient Age66 YR
Patient Weight64
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