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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH MAGNETOM VERIO 3T MRI SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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SIEMENS AG/SIEMENS HEALTHCARE GMBH MAGNETOM VERIO 3T MRI SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hearing Impairment (1881); Pain (1994); Tinnitus (2103); Discomfort (2330); Increased Sensitivity (4538)
Event Date 12/25/2020
Event Type  Injury  
Event Description
I went to (b)(6) for a mri scan of my right hip. I was told it was a 3t mri lasting around 20 minutes. I had been given a pair of plastic headphones to "protect my ears" before i went inside the machine. Right after the mri i noticed my hearing had changed. The symptoms were muffled hearing, with right ear more muffled than left, ringing in the ears, pain in the ears and sensitivity to sounds. The inside of my ear also felt warm and there was a feeling of pressure. I was not given earplugs or any other equipment meant to protect hearing. I had raised my concerns to the employee getting me out of the machine and she had admitted that the headphones does not do a good job of protecting hearing, which strikes me as strange especially since i was not informed that undergoing the mri would cause hearing loss and hearing problems. It has been 3 months since then and i am still having symptoms of discomfort and tinnitus. Sounds sound like they are farther away and i have trouble focusing on details of sounds and music. I have seen several doctors and there really isn't anything anyone can do since once the hair cell in the inner dies they cannot regenerate. Fda safety report id#: (b)(4).
 
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Brand NameMAGNETOM VERIO 3T MRI
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS AG/SIEMENS HEALTHCARE GMBH
MDR Report Key11574289
MDR Text Key242709902
Report NumberMW5100274
Device Sequence Number1
Product Code LNH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/25/2021 Patient Sequence Number: 1
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