MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 4968

Device Problems High impedance (1291); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the right atrial (ra) lead exhibited high out-of-range (oor) pacing impedances, measuring greater than 2000 ohms.It was noted there was no noise and the physician suspected a connection issue.Technical services (ts) discussed the intermittent high impedances could be due to a spring contact issue in the device header, and recommended reprogramming the lead to unipolar pacing and bipolar sensing.This ra lead remains in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT PACEMAKER ELECTRODE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17534082
• MDR Text Key: 321371470
• Report Number: MW5140985
• Device Sequence Number: 1
• Product Code: DTB
• 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: 11/27/2019

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: 4968
• Patient Sequence Number: 1