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

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).

• Brand Name: MAGNETOM VERIO 3T MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 11574289
• MDR Text Key: 242709902
• Report Number: MW5100274
• 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
• 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 Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 23 YR
• Patient Weight: 65