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

Model Number 1258T

Device Problem Signal Artifact/Noise (1036)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this left ventricular (lv) lead exhibited dips in lv pace impedance measurements which remained within normal range.Reprogramming was performed in which noise was observed.Noise was also observed when the patient moved.There was no indication or observation of oversensing.Technical services recommended follow up with the electrophysiologist.The lead remains in service.No 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: 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: 17525641
• MDR Text Key: 321271985
• Report Number: MW5132582
• 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: 03/08/2021

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