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

Model Number MEDTRONIC ATTAIN

Device Problems Failure to Capture (1081); High impedance (1291); Pacing Problem (1439)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2012 and remains implanted at this time.This was noted due to left ventricular lead is out of order.The threshold is greater than 7.5v whatever the vector, impedance trend shows a strong increase since mid june and loss of capture.The physician was (b)(6).The (b)(6) facility was at (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: 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: 17537521
• MDR Text Key: 321268320
• Report Number: MW5144398
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MEDTRONIC ATTAIN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1