MAUDE Adverse Event Report: MRI

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Subarachnoid (1893)
Date of Event	08/12/2016
Type of Reportable Event	Death
Event or Problem 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
• Common Device Name: MRI
• MDR Report Key: 5895839
• Report Number: MW5064230
• Device Sequence Number: 1203577
• Product Code: LNH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

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