MAUDE Adverse Event Report: MEDTRONIC DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 4296

Device Problems Pacing Inadequately (1442); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This lv lead was implanted on an (b)(6) 2012 and remains implanted at this time.In a product experience report received on (b)(6) 2018 it was noted that threshold for this lead increased.It increased from lv ring to rv from 1.7/0.4ms to 6v/1.0ms.Result from each induction check it was 2.2v/0.4ms at lv tip to rv.Decreased qrs amplitude was also noted.Threshold configuration was lowered and patient will be checked again in a week.The physician was dr.(b)(6) at (b)(6) center in (b)(6), japan.No other information available.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): MEDTRONIC
• MDR Report Key: 17527979
• MDR Text Key: 321411688
• Report Number: MW5134910
• 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: 07/10/2018

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: 4296
• Patient Sequence Number: 1