MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 4076

Device Problems Failure to Capture (1081); High Sensing Threshold (2574); Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 2014 and remains implanted as of this time.A call was placed to technical services on (b)(6) 2018 stating that there was a poor atrial sensing and higher threshold - 3.4/3.5v with output set at 3.5v.A lost of capture was also noted and the strip shows minute ventilation chop.The following physician was dr.(b)(6) at (b)(6) hospital in (b)(6).No other information is available.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: 17536631
• MDR Text Key: 321450169
• Report Number: MW5143515
• 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: 10/17/2018

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: 4076
• Patient Sequence Number: 1