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

Model Number 4296

Device Problem Signal Artifact/Noise (1036)

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Swelling/ Edema (4577)

Event Date 08/30/2013

Event Type  Injury  

Event Description

A call to technical services was made on 10/28/2013 stating that this lead was experiencing noise on (b)(6) 2013 with asystole for > 1 o seconds.The patient had an rv threshold of 6 v @ 1.5 msec.Patient had complaints of shortness of breath and fluid retention.The lead was implanted on (b)(6) 2012 and is still in active use.The physician was dr.(b)(6) at (b)(6) associates in (b)(6), nc.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: 17529708
• MDR Text Key: 321136518
• Report Number: MW5136632
• 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: 12/17/2013

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