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

Model Number 7120

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that lead was surgically abandoned due to unknown product performance issue.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DURATA LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17537473
• MDR Text Key: 321173917
• Report Number: MW5144351
• 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: 11/02/2020

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: 7120
• Patient Sequence Number: 1