MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH ESPREE 2008 MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number ESPREE 2008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tinnitus (2103); No Code Available (3191)

Event Date 08/03/2012

Event Type  Injury  

Event Description

I had an enclosed mri with contrast (b)(6) 2012 for a spinal issue.I wore 30 decibel hearing protection.Since this time i have been diagnosed with severe, and disabling multiple tinnitus and severe hyperacusis or loudness h.Which means i have auditory gain.All environmental sounds, sounds much louder than it really is.I also pick up on electronic frequencies.I have gone from an active senior adult, to a "shut in".I have seen many doctors and there does not seem to be anything they can do.

• Brand Name: ESPREE 2008 MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 8371636
• MDR Text Key: 137360026
• Report Number: MW5084375
• Device Sequence Number: 0
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESPREE 2008
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 60 YR
• Patient Weight: 55