MAUDE Adverse Event Report: MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES; PERMANENT PACEMAKER ELECTRODE

Model Number 6935

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2016

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2009 and was capped on (b)(6) 2016 due to unknown product performance issue.The physician was dr.(b)(6) at (b)(6) hospital an medical center 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 DEFIBRILLATOR ELECTRODES
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17527297
• MDR Text Key: 321320055
• Report Number: MW5134230
• 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: 01/13/2017

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: 6935
• Patient Sequence Number: 1