MAUDE Adverse Event Report: MEDTRONIC AZURE S DR MRI; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number W3DR01

Device Problems Display or Visual Feedback Problem (1184); Over-Sensing (1438)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

Alert: atrial unipolar lead impedance warning on (b)(6) 2021--a unipolar lead impedance 190 ohms-threshold 200 ohms device appears to be oversensing on the atrial lead possibly leading to inappropriate event detection.124 monitored at/af episodes most recent (b)(6) 2022.P-waves measure 1.5/sensitivity is programmed 0.3mv.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AZURE S DR MRI
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17536472
• MDR Text Key: 321181581
• Report Number: MW5143360
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: W3DR01
• Patient Sequence Number: 1