MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 5076

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)

Event Type  Injury  

Event Description

This lead was used as an external temporary lead.A product experience report received on 08/30/2018 stated that an entire system was extracted due to infection and erosion with sepsis.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: 17534952
• MDR Text Key: 321136256
• Report Number: MW5141852
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5076
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1