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

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Caller mentioned that mri guidelines from other manufacturers are "always" confusing.Medtronic reference number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488479
• MDR Text Key: 320698794
• Report Number: MW5121178
• 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: Other
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1