MAUDE Adverse Event Report: ST. JUDE MEDICAL PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 1581

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2016

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2003 and was capped on (b)(6) 2016 due to an unknown product performance issue.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 DEFIBRILLATOR ELECTRODES
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17535954
• MDR Text Key: 321407066
• Report Number: MW5142846
• 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: 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: 1581
• Patient Sequence Number: 1