MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH MAGNETOM TERRE 7T MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Dyspnea (1816); Muscle Spasm(s) (1966); Neurological Deficit/Dysfunction (1982); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)

Event Date 05/02/2020

Event Type  Injury  

Event Description

Scheduled for 3 mri same afternoon at (b)(6) hospital (b)(6): cervical, thoracic and lumbar to determine status of low back as consideration being made to surgically proceed with high cervical to mid thoracic fusion w/ instrumentation due to mass effect on spinal cord at t2.During cervical portion of mri (machine: 7t magnetom terre by siemens medical solutions) burning occurred in chest, advised tech of shortness of breath with loss of sensation to right arm.She pulled me out of machine, no sensation rt arm, she applied a bolster under shoulder and continued with testing to thoracic region.Burning continued in my chest.When working on lumbar area intense burning occurred with spasm of rt leg.At this point i used my rt arm to hold down the thigh of my rt leg.Tech advised to hold still and was i ok.I repeated over and over that i was not ok.I was not ok as rt leg was exploding with pain and spasm and i was not able to hold it steady.Tech kept repeating 3 more minutes, 3 more minutes.I was crying during the last 6 minutes due to extraordinary pain.There was no motor or sensory function of my rt leg when pulled out of machine, needing assistance to sit up and then stand.Due to covid, no one was with me.It was unsafe to drive home but did, rt arm now in spasm, a new finding.My rt leg has never stopped explosive pain since that day, sleep evades me.My lower left leg loses function with ambulation.The machine is unsafe.What might be my recourse.I am an rn, ccm, crrn with a specialty in head injury and spinal cord injury rehab; i was a former auditor for (b)(6); i am now retired.No one should experience this, no future patient should experience this.Fda safety report id# (b)(4).

• Brand Name: MAGNETOM TERRE 7T MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 10075591
• MDR Text Key: 191833858
• Report Number: MW5094605
• 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: 05/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• 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 Number: 1
• Patient Outcome(s): Disability
• Patient Age: 75 YR
• Patient Weight: 88