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

Device Problem Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); Numbness (2415)

Event Date 10/16/2018

Event Type  Injury  

Event Description

Had to fill out the form your way.It's really just a side effect no one can seem to answer, and to be prevented from any risk of harm i was banned from this.Which i'm ok with just need you to find out how and why.I had an mri done a long time ago on my leg.So my legs were inside the magnet, and my body was outside.During 4 of the tests, i noticed my body went 100% numb.I "laterally" couldn't feel anything and it felt like i was just a head.There was no tingling at all when the feeling came back after the tests had finished.Due to this, i was told to never use a 3t magnet again and to try a 2t open mri, which i did, the radiologist was super cool and was skeptical "bout" letting me in due to the problem reported in the 1st one.The leader of radiology allowed me to try.During the open mri, i was able to feel a heavy "pitter patter" across my chest like a house "can" walking on me with the magnet waves.We tried 3 tests.During the 1 min test, of the heavier magnet field of scan, i could feel the waves feels as though they were painlessly slicing through my body and tracing my organs.Once the scan reached my spine, my body had tensed up, and i started shaking like i had a severe caffeine rush.I was pulled from the machine right away and told to get out of the room and field.We had an xray done and there appeared to be no metals in me anywhere.So why would this happen? why would i go numb, or feel it like i did? no one in the "hosp" could answer it.Some neurologists also suggested to sedate me, but 1 radiologist said no, because that would be too dangerous, because then i couldn't speak up if i felt something bad happen.Thank you.

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESPONSE IMAGING
• MDR Report Key: 7979765
• MDR Text Key: 124793760
• Report Number: MW5080682
• 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: 10/16/2018

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: 10/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 64