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

Model Number 4298

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Device Overstimulation of Tissue (1991); Discomfort (2330)

Event Type  malfunction  

Event Description

This lv lead was implanted on (b)(6) 2015 and remains implanted as of this time.A call was placed to technical services on (b)(6) 2018 stating that the patient had an experienced diaphragmatic stimulation and the lv lead had a reprogramming to resolved this issue.The stimulation occurred a couple years ago.Patient pointing toward her left side and feels symptoms about once a week for 1-2 beats.Lv output is 2v.Threshold is 1.5v.The following physician was dr.(b)(6) at (b)(6) hospital at the (b)(6).No other information is 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: 17534413
• MDR Text Key: 321466572
• Report Number: MW5141314
• 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: 10/17/2018

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: 4298
• Patient Sequence Number: 1