MAUDE Adverse Event Report: MEDTRONIC DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 5086MRI

Device Problems Pacing Inadequately (1442); Under-Sensing (1661)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead exhibited undersensing of r-waves, resulting in the device providing pacing when not required.In addition, there was noise exhibited on the rv channel.The patient is not dependent.Unknown if a change in patient condition is a result of the observations.Technical services (ts) recommended further evaluation with following physician.The rv lead remains in service.No adverse patient effects reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17530918
• MDR Text Key: 321408597
• Report Number: MW5137834
• Device Sequence Number: 1
• Product Code: NVN
• 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: 04/27/2021

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: 5086MRI
• Patient Sequence Number: 1