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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS SIEMENS TIM TRIO 3T

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SIEMENS SIEMENS TIM TRIO 3T Back to Search Results
Device Problem Electromagnetic Compatibility Problem (2927)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 10/02/2017
Event Type  Injury  
Event Description
Mri adverse event: we had a senior patient for a research study not inform us that she had a spinal stimulator. She did not mark it on the mri screening form nor did she acknowledge the implant during the verbal questioning about metal/devices. Patient stated she forgot about the implant. We put her in a 3t mri scanner for a head study, we completed the localizer and a 3d t2 flair sequence. The mri tech went into the room to talk with the patient since she could not hear us through the intercom. Upon asking if she was ok, she stated she forgot to tell us about a clip the doctor had put in to help her with her bowel which we found later to be a spinal stimulator. She also stated that she had felt a sensation from her groin down her left leg and into her left good. At this point the procedure was immediately halted and the patient removed slowly from the mri scanner. The patient did not complain of any pain and was able to walk out of the mri room without any complaint. We informed the study coordinator and the pi of the study as soon as we removed the patient from the mri area.
 
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Brand NameSIEMENS TIM TRIO 3T
Type of DeviceSIEMENS TIM TRIO 3T
Manufacturer (Section D)
SIEMENS
MDR Report Key6922074
MDR Text Key89113309
Report NumberMW5072630
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
Type of Report Initial
Report Date 10/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
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

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