MAUDE Adverse Event Report: EDWARDS EDWARDS INTUITY; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number EDWARDS INTUITY ELITE

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Heart Block (4444)

Event Type  Injury  

Event Description

Medtronic received information that post-operatively of an edwards valve implant, left bundle branch block was noted.A temporary pacemaker was turned on.Three days post-operative the patient presented with bradycardia.Four days post-operative the patient converted in and out of atrial fibrillation and sinus bradycardia.A permanent pacemaker was inserted on the same day for sinus node dysfunction/bradycardia.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: EDWARDS INTUITY
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS
• MDR Report Key: 17532673
• MDR Text Key: 321143371
• Report Number: MW5139580
• Device Sequence Number: 1
• Product Code: LWR
• 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: 01/24/2018

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
• Device Model Number: EDWARDS INTUITY ELITE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1