MAUDE Adverse Event Report: MRI

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.

• Brand Name: MRI
• Type of Device: MRI
• MDR Report Key: 5895839
• MDR Text Key: 52847169
• Report Number: MW5064230
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 77