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

Model Number 2088TC

Device Problems Under-Sensing (1661); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Undersensing noted on atrial lead during at/af episodes causing false termination of some "episodes" (b)(4).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: 17537591
• MDR Text Key: 321047587
• Report Number: MW5144463
• 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: 03/01/2021

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: 2088TC
• Patient Sequence Number: 1