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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI

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Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893)
Event Date 08/12/2016
Event Type  Death  
Event Description
My father had an mri of the spine ordered at (b)(6) center. He has a history of a craniotomy for aneurysm clipping in 1982, and should not have an mri due to the risk of migration of clips and possible bleeding. Md well aware of his history, and ordered mri anyway. During the mri, my father became unresponsive and was posturing. A f/u ct scan of the brain showed a massive subarachnoid hemorrhage. He passed away about 15 hours later. After the mri and hemorrhage event, md came to speak to my mother, and informed her that they had made a mistake, and that the mri should never have been ordered, and likely caused the massive brain hemorrhage. I am concerned that they ordered this test, being well aware of the fact that my father had aneurysm clips in his brain, as this was documented in his admitting h&p, by the very md that ordered the mri. Please investigate.
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Brand NameMRI
Type of DeviceMRI
MDR Report Key5895839
MDR Text Key52847169
Report NumberMW5064230
Device Sequence Number1
Product Code LNH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 08/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2016
Is this an Adverse Event 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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/18/2016 Patient Sequence Number: 1