MAUDE Adverse Event Report: EDWARDS ELECTRODE, PACEMAKER, TEMPORARY

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

Medtronic received information that following the implant of this transcatheter bioprosthetic valve, the patient was found to have a pericardia effusion that caused a myocardial tamponade.A pericardiocentesis was performed and a pericardia drain was placed.Additional information was received that the physicians feel the perforation happened when the edwards pacing catheter was placed in the right ventricle.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ELECTRODE, PACEMAKER, TEMPORARY
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS
• MDR Report Key: 17527773
• MDR Text Key: 321057515
• Report Number: MW5134704
• Device Sequence Number: 1
• Product Code: LDF
• 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: 11/05/2014

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
• Patient Sequence Number: 1
• Treatment: MEDTRONIC AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY.