MAUDE Adverse Event Report: MRI SCANNER; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Tinnitus (2103); Tingling (2171)

Event Date 06/23/2019

Event Type  Injury  

Event Description

Underwent an mri of the cervical spine.During the mri, experienced constant abdominal muscle twitching while the machine was in operation.Additionally, experienced ringing in the ears during the same time.Also right eye pain which continues to persist.

• Brand Name: MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 8758449
• MDR Text Key: 150215057
• Report Number: MW5087818
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 91