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U.S. Department of Health and Human Services

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

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SIEMENS AG/SIEMENS HEALTHCARE GMBH MAGNETOM TERRE 7T MRI SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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).
 
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Brand NameMAGNETOM TERRE 7T MRI
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS AG/SIEMENS HEALTHCARE GMBH
MDR Report Key10075591
MDR Text Key191833858
Report NumberMW5094605
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received05/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/19/2020 Patient Sequence Number: 1
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