MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA; HEART-VALVE, MECHANICAL

Model Number TRIFECTA: TF23A

Device Problem Insufficient Information (3190)

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

Medtronic received information that on the day of valve implant, this patient developed a 3rd degree atrioventricular (av) block.Thirteen days post valve implant, a permanent pacemaker was implanted.No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRIFECTA
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17536160
• MDR Text Key: 321140253
• Report Number: MW5143050
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 11/26/2018

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: TRIFECTA: TF23A
• Device Lot Number: 14969166
• Patient Sequence Number: 1