MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC REVEAL XT MONITOR

Model Number 9529

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2016

Event Type  Other  

Event Description

Outpatient scanned in error on mri 1.2t.Low field magnet instead of recommended 1.5t.No adverse effects or complications noted.F/u with pt revealed no complaints.Pt's doctor's office also notified.Pt instructed to do manual upload on device.

• Brand Name: MEDTRONIC REVEAL XT MONITOR
• Type of Device: REVEAL XT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6016669
• MDR Text Key: 57259814
• Report Number: MW5065260
• Device Sequence Number: 1
• Product Code: DSI
• 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: 10/06/2016

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
• Device Operator: Health Professional
• Device Model Number: 9529
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 72