MAUDE Adverse Event Report: SORIN HEART-VALVE, MECHANICAL

Device Problem Insufficient Information (3190)

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Event Description

Medtronic received information that two days following the implant of this transcatheter bioprosthetic valve, ventricular standstill was noted and a temporary pacing wire was placed.Two days after the temporary pacing wire was placed a permanent pacemaker was implanted.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HEART-VALVE, MECHANICAL
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): SORIN
• MDR Report Key: 17524046
• MDR Text Key: 321131759
• Report Number: MW5130993
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1