MAUDE Adverse Event Report: MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 3830

Device Problems Malposition of Device (2616); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6)2017 and was explanted on (b)(6)2018 due to a product performance issue.A product experience report was received on 06/01/2018 stating that this lead was positioned in his location resulted in high pacing thresholds and rapid pacemaker battery depletion 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 DEFIBRILLATOR ELECTRODES
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17537168
• MDR Text Key: 321369468
• Report Number: MW5144048
• Device Sequence Number: 1
• Product Code: NVY
• 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: 3830
• Patient Sequence Number: 1