MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC PACEL; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 401764

Patient Problem Failure of Implant (1924)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

Tavr (transcatheter aortic valve replacement) procedure.Temporary pacemaker.Pacel inserted into lv.Unable to sense and capture.Pacemaker removed and new one inserted.No problem with second device.

• Brand Name: PACEL
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 18159459
• MDR Text Key: 328397610
• Report Number: 18159459
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 401764
• Device Catalogue Number: 401764
• Device Lot Number: 909600
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1