MAUDE Adverse Event Report: SIEMENS HEALTHCARE LIMITED SIEMENS MRI VERIO 3T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Inadequate User Interface (2958)

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

Event Date 03/12/2021

Event Type  Injury  

Event Description

Patient came for mri scan and reported to have no implants.Patient came back weeks later for a second scan but this time was reported to not be able to answer screening questions.Due to this a screening by the radiologist, using films was conducted to screen that patient.It was during this time that the retained leads were found.Fda safety report id # (b)(4).

• Brand Name: SIEMENS MRI VERIO 3T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE LIMITED
• MDR Report Key: 11744538
• MDR Text Key: 248239904
• Report Number: MW5101066
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other