MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Pain (1994); Neck Pain (2433)

Event Date 09/11/2018

Event Type  Injury  

Event Description

I felt a sharp painful contact go through my lower back and neck during an mri at the (b)(6).I am still under the care of a medical doctor for this injury caused by this medical device.

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• MDR Report Key: 8115698
• MDR Text Key: 129042491
• Report Number: MW5081717
• Device Sequence Number: 1
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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): Disability
• Patient Age: 62 YR
• Patient Weight: 45