MAUDE Adverse Event Report: MEDTRONIC ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6490

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 04/25/2018

Event Type  Injury  

Event Description

This ra lead was implanted on (b)(6) 2000.And was capped on (b)(6) 2018, due to infection.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: ELECTRODE, PACEMAKER, TEMPORARY
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17527474
• MDR Text Key: 321062470
• Report Number: MW5134406
• Device Sequence Number: 1
• Product Code: LDF
• 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: 07/10/2018

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: 6490
• Patient Sequence Number: 1