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

Device Problem Material Puncture/Hole (1504)

Patient Problem Cardiac Tamponade (2226)

Event Type  Injury  

Event Description

On 10 march 2011, medtronic corevalve received information that during the implant of this bioprosthetic valve, the temporary pacing electrode (st.Jude, straight tip) punctured the heart causing tamponade.The patient was taken to surgery to repair the puncture and is recovering well.The valve was successfully implanted.(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): ST. JUDE MEDICAL
• MDR Report Key: 17532927
• MDR Text Key: 321049199
• Report Number: MW5139833
• 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