MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL; ELECTRODE, PACEMAKER, TEMPORARY

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Death  

Event Description

On (b)(6) 2011, medtronic corevalve received information.That 22 hours following the implant of this bioprosthetic valve.The patient died, due to perforation of the right ventricle by the st.Jude pacel 6f temporary pacing lead (not balloon tipped), causing a pericardia effusion and tamponade.It is also reported, that the patient possibly had a myocardial infarction.This was not confirmed.There were no other complications with the implant of the valve.A proctor was present at implant.The valve was situated high in the aorta.Post implant, there was grade i aortic insufficiency.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PACEL
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17531130
• MDR Text Key: 321041387
• Report Number: MW5138045
• 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: 03/25/2011

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