MAUDE Adverse Event Report: ST. JUDE MEDICAL DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 1258T

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead exhibited noise, high threshold, and varied high out of range pace impedance measurements ranging from 500 ohms to greater than 3000 ohms.It was noted the patient experienced diaphragmatic stimulation in several configurations and has complete heart block after av node ablation.No adverse patient effects were reported.The lead remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17536809
• MDR Text Key: 321151393
• Report Number: MW5143693
• Device Sequence Number: 1
• Product Code: OJX
• 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: 08/12/2021

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: 1258T
• Patient Sequence Number: 1