MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 4558M

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 09/19/2007

Event Type  Injury  

Event Description

This ra lead was implanted on (b)(6) 2009 and was capped on (b)(6) 2007.A product experience report was received on date 9/19/2017 due to infection and erosion.The physician was dr.(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: 17536512
• MDR Text Key: 321143946
• Report Number: MW5143399
• 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: 10/17/2017

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: 4558M
• Patient Sequence Number: 1