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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS AG / SIEMENS HEALTHCARE GMBH MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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SIEMENS AG / SIEMENS HEALTHCARE GMBH MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number ESPREE 2008
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hearing Loss (1882); Tinnitus (2103)
Event Date 03/08/2012
Event Type  Injury  
Event Description
Hearing has been permanently damaged after an enclosed mri with contrast for the lower back at the (b)(6) hosp in (b)(6).Siemens magnetom espree 2008 model.Was wearing silicone ear plugs and some small ear muffs for hearing protection but it was not enough.The machine has the potential to reach 129 db at maximum output.I was never given any instructions about hearing protection needed.Other serious / important medical incident: intrusive tinnitus (multiple sounds that change constantly) hyperacusis (amplified hearing, auditory gain), i.E.Normal sounds are perceived much louder any normal person would perceive them.I have been diagnosed with severe tinnitus and severe hyperacusis, (i hear all sounds, much louder / amplified than they really are) i have been like this for almost seven years.It is my understanding they have used different muffs since this incident.My ent states in her letter to my gp "i am functional disabled" i was once an active person, who now lives a reclusive life.
 
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Brand Name
MRI MACHINE
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS AG / SIEMENS HEALTHCARE GMBH
MDR Report Key8627814
MDR Text Key145844985
Report NumberMW5086785
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 Patient Family Member or Friend
Type of Report Initial
Report Date 05/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberESPREE 2008
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age60 YR
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