MAUDE Adverse Event Report: PACESETTER PERMANENT PACEMAKER ELECTRODE

Model Number 1388TC

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/30/2008

Event Type  Injury  

Event Description

This lead was implanted on (b)(6) 2002, was capped on (b)(6) 2008 and was explanted on (b)(6) 2018 due to infection.The 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): PACESETTER
• MDR Report Key: 17535697
• MDR Text Key: 321135434
• Report Number: MW5142592
• 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: 1388TC
• Patient Sequence Number: 1