TESLA 1.5 MRI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for TESLA 1.5 MRI manufactured by Unk.

Event Text Entries

[176294851] Third degree burn mri exam. On (b)(6) 2018. I was experiencing symptoms similar to when i first had to have spinal fusion surgery in (b)(6). After speaking with the neurosurgeon and telling him about what i was experiencing, he advised me to go back to the er at (b)(6) for mri to rule out any complications due to the original surgery. The er doctors ran a battery of tests; heart, urine, etc. I had the heart mentor leads attached the entire time. After waiting for hours in er, i was taken for the mri between 12 an 2am. The mri technician who brought me in for the test did not ask me to remove any jewelry or ask if i had anything on my body that would be cause for concern during the mri> the only thing he said was ,? Be prepared to stay still for 2 and a half hours to avoid having to start the test over. Press the button in case of an emergency. ? The technician put me in the tub and very shortly after (within 5 minutes) i felt a burning sensation on my chest. I pressed the emergency button, which passed the test and the technician came into the room to check on me. I told him i was feeling burning on my neck/chest and he asked why? Only then did he realize that the chain was not removed. The technician removed the chain for me without looking for any additional areas of concern. He then proceeded to tell me,? Now we need to start all over again.? The technician put me back into the tube to restart the mri. During the 2? Hour mri, i left a weird sensation on my chest, but i just assumed i was okay since the technician just took the chain off me. I assumed he was qualified and would have completed a pretest checklist to avoid any injury. I remained in the hospital for 4 days for further testing-spinal tap. While in the hospital, i did not shower because i was unsteady on my feet. On the 4th day, when i was finally being discharged, and i changed my clothes, i then noticed two reddish looking circles on my chest that were oozing a clear liquid. I had the nurse, (b)(6) look at it and she said they were burns from the heart leads during the mri. She gave me antibiotic ointment and told me to rub it on the burns and f/u with my primary dr. A day after i was home, the marks on my chest were redder in color, larger in size than the day prior, and began to hurt. They were still oozing a clear liquid that was noticeable on my t-shirt. I went to my primary dr, dr (b)(6), (affiliated with (b)(6)) for her to check the marks. She confirmed if they were burns and then was realized the heart monitor leads were left on during the mri. The metal from the leads caused the burns. She called them thermal burns and that they would get worse before they got better. Dr (b)(6) said thermal burns start from the inside and surface gradually, so they will get worse substantially. They would most likely scar and if not treated could become infected. I have two larger scars on both sides of my chest where the leads were left on me. After realizing the negligence on the hospital? S behalf not checking to see if there was anything on me that could cause harm i proceeded to file a complaint with patient relations at the hospital. I called and spoke to an employee there. I was asked if i wanted an investigation completed. I said,? Yes, of course. ? She said they would interview the staff, review the procedural logs and it could take up to 30 days to hear back. After the 30 days, i received a copy of the report that indicated there was no negligence founded on their behalf. At that point i filed a complaint with the department of health hoping an outside source would see all the facts from an unbiased perspective. I felt the hospital was covering up their mistake. When i submitted my complaint with the department of health, they sent out a team to do a 5 day investigation on my claim. I was informed that they went to the hospital so quickly and aggressively because this was seen as a? Never event?. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092483
MDR Report Key9628576
Date Received2020-01-24
Date of Report2020-01-22
Date of Event2018-04-26
Date Added to Maude2020-01-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTESLA 1.5 MRI
Generic NameSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Product CodeLNH
Date Received2020-01-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-24

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