MAUDE Adverse Event Report: MRI MACHINE

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Itching Sensation (1943); Rash (2033); Shock (2072); Visual Disturbances (2140); Vomiting (2144); Dizziness (2194); Complaint, Ill-Defined (2331); Palpitations (2467); Pallor (2468); Shaking/Tremors (2515); Burn, Thermal (2530)

Event Date 12/09/2016

Event Type  Injury  

Event Description

I was told by the neurologist i was seeing at the time that i needed an mri of my brain due to multiple brain injuries.I went to this company called (b)(6) to have the non contrasted mri scan performed on (b)(6) 2016.I was placed into a gown and told to lay on the table with my arms crossed across my chest at heart level and my ankles crossed, left over right.I was placed into the enclosed machine which i have been before as this wasn't my first mri.Once the machine started up and the testing was starting out of the low pulse tones i felt a sharp electrical shock enter my right shoulder and exit out the tips of my toes.I hit the plunger button to notify the tech what was going on to which he became irritated that i interrupted him.He pulled me out of the tube at which i told him what happened and that i was feeling light headed and was experiencing heart palpitations.The tech then informed me very rudely that there was no way that i received a shock from the machine and that it was perfectly safe and had no reactions like that.I must have punched a nerve in my neck to cause this.He at the time asked me if i wanted to go back into the machine, or did i want to waste his time and be a quitter! i agreed to give it another try but i wanted to position myself where i was comfortable.I was told by the same tech that i had to have my arms crossed as well as my ankles, that i couldn't have them besides me.The test started up again to which i laid perfectly still as instructed.Once the low pulse tones of the mri machine started in i was shocked again.I informed the tech to which he passed it off as nothing and told me i had 5 images left to hang in there.Every time the machine hit that low pulse i was shocked, resulting in 5 shocks total.When it was all said and done i was seeing black spots, so light headed that i felt like i was going to pass out.My head hurt so bad, my heart palpitations were bad and i felt like i was going to vomit.I tried to inform the other tech about this, but he was in a hurry to clean the room and wouldn't listen.I left to get dressed, and my husband noticed that something was wrong with me as i was super pale and shaking.Once outside in my husband's truck i became violently ill with vomiting and itching all over my chest, arms and legs.We noticed a rash in the same areas as well as when i got home he spotted two small burn marks on my ankles and big toes.I tried to tell the women at the front desk before i left what happened, but they were too busy looking and buying baby things on the work computer.I was seen the following monday ((b)(6) 2016) by my primary care provider and she ran an ekg to make sure the shocks didn't affect my heart.I also told my neurologist about this incident to which she demanded that i don't tell anyone and became mad when i told her that i told my primary care doctor.She dismissed me as her patient over this event!.

• Brand Name: MRI MACHINE
• Type of Device: MRI MACHINE
• MDR Report Key: 6279454
• MDR Text Key: 65961541
• Report Number: MW5067488
• Device Sequence Number: 1
• Product Code: LNH
• 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: 01/24/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: DIMETAPP AS NEEDED FOR ALLERGIES. ; RX MEDS: MORTIN 600 MG AS NEEDED FOR PAIN OR FEVER
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 86