MAUDE Adverse Event Report: ST. JUDE MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1056T

Device Problems Pacemaker Found in Back-Up Mode (1440); Defibrillation/Stimulation Problem (1573)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  malfunction  

Event Description

This lv lead was implanted on (b)(6) 2006 and remains implanted at this time.A call placed to technical services on 4/18/2013 states patient reported some diaphragmatic stimulation.Representative stated upon interrogation, observed lead safety switch on l v lead had switched from bipolar to unipolar.Lead safety switched was tripped (b)(6) 2013 due to lv impedance less than 200ohms.Good thresholds, sensing and impedances unipolar.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).No additional information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17529783
• MDR Text Key: 321281801
• Report Number: MW5136706
• Device Sequence Number: 1
• Product Code: NIK
• 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: 06/17/2013

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: 1056T
• Patient Sequence Number: 1