MAUDE Adverse Event Report: MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 4592

Device Problems Failure to Capture (1081); Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2017

Event Type  malfunction  

Event Description

This ra lead was implanted in (b)(6) 2004 and was capped and abandoned on (b)(6) 2017.It was noted in a report received by medical records on september 07, 2017 that the indications for procedure done on (b)(6) 2017 were failure to capture, failure to sense and other conduts.Patient's heart rate was 11 up to 140 bpm in the operating room.The physician was dr.(b)(6) at (b)(6).No other information 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: 17533502
• MDR Text Key: 321419983
• Report Number: MW5140406
• 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: 10/17/2017

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: 4592
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1