MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM

Model Number LSP201A

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559); Device Dislodged or Dislocated (2923)

Patient Problem Embolism/Embolus (4438)

Event Date 04/04/2024

Event Type  Injury  

Event Description

It was reported that the patient presented for follow-up.Upon interrogation, it was found that the leadless pacemaker exhibited failure to sense, failure to capture, and high impedance.X-ray was performed and verified that the leadless pacemaker had dislodged and traveled outside its intended chamber.The leadless pacemaker was retrieved.The patient was stable.

• Brand Name: AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM
• Type of Device: Leadless pacemaker
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19173535
• MDR Text Key: 340936401
• Report Number: 2017865-2024-39509
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067040701
• UDI-Public: (01)05415067040701(10)S000092003(17)241010
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP201A
• Device Lot Number: S000092003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AVEIR LEADLESS PACEMAKER, VENTRICULAR.
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female