MAUDE Adverse Event Report: ST. JUDE SIZER, HEART-VALVE, PROSTHESIS

Model Number TF-21A

Device Problem Insufficient Information (3190)

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

Medtronic received information that 30 days following implantation of the bioprosethetic valve, the patient had an ekg that revealed complete heart block and a crt-d permanent pacemaker implanted.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIZER, HEART-VALVE, PROSTHESIS
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17523078
• MDR Text Key: 321054516
• Report Number: MW5130026
• Device Sequence Number: 1
• Product Code: DTI
• 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: 03/01/2018

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: TF-21A
• Device Lot Number: 14377471
• Patient Sequence Number: 1