MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 3T MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Edema (1820); Bone Fracture(s) (1870); Laceration(s) (1946); Necrosis (1971); Sweating (2444); Palpitations (2467); Ambulation Difficulties (2544); Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/19/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 i had an mri in a ge 3t machine at the (b)(6) hospital ((b)(6)) in (b)(6) in preparation for an implantable tens unit.During approximately 1 hr and 20 minutes mri, i began to sweat profusely and my heart began to pound.I also felt an area of a burning sensation in my lower back and asked the technician to stop the mri but he didn't.I then drove home and had my wife look at the area.I had a 6x9 inch area of visible burn.The event was reported to my doctor (with photos) and i was seen in the burn department at (b)(6) on (b)(6) 2020 and was given lubriderm for the visible burn.Beginning 5 days after the burn, i began having internal pain in a t shape in my groin and coccygeal/perineal area.This pain worsened and i was seen multiple times at the emergency department at (b)(6) and given pain medication.As time progressed, i developed extreme difficulty sitting due to intense pain and walking became almost impossible.(i have a video of this if needed.) i was admitted to (b)(6) on (b)(6) 2020 where i was put on oxycodone, fentanyl patch and iv dilaudid to control the pain.I had another mri done which revealed extensive edema and enhancement within the bilateral pubic bones with fluid signal in the pubic symphyseal joint.Findings were suggestive of osteitis pubis.There was degenerative tearing of the anterior superior acetabular labrum bilaterally.There was edema and enhancement seen at the myotendinous junction and distal tendon of the right rectus abdominis.There was edema and enhancement involving the right adductor longus and brevis muscle bellies near the attachment to the pubic symphysis.Within the right adductor longus muscle belly region of edema there were regions of non enhancement which measured up to 1.3 cm and were suggestive of myonecrosis.There was edema and enhancement associated with bilateral obturator internus muscles.On (b)(6) 2020 i was transferred to a skilled nursing facility until readmission to (b)(6) for increased edema on (b)(6) 2020.During that hospitalization it was determined that i had a nondisplaced insufficiency fracture of the medial left inferior pubic ramus and fluid within the pubic symphysis extending along the inferior margin of the right pubic bone obliquely, compatible with partial tearing of the right abductor longus tendon origin.There was also cortical loss/erosion of the anterior portion of the right pubic body.I was discharged home on (b)(6) 2020.Prior to the burn on (b)(6) 2020, i was an active individual living in a rural area and maintaining our vacation rental home.My health has taken a significant nosedive since the mri burn and i am currently walking with a walker and unable to carry on with my life as previously.My new primary care physician, dr.(b)(6) in (b)(6) agrees that this all stems from the mri burn.I continued to have difficulty walking and am unable to sit.I either have to stand or recline.I believe this is all due to damaged tissue and bone which is the result of the mri burn i sustained.Fda safety report id # (b)(4).

• Brand Name: GE 3T MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC
• MDR Report Key: 11100474
• MDR Text Key: 224864707
• Report Number: MW5098599
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): Y
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 132