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

Model Number LSP202V

Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923)

Patient Problem Arrhythmia (1721)

Event Date 01/15/2024

Event Type  malfunction  

Event Description

It was reported the patient presented for implant procedure.During surgery, the right ventricular (rv) leadless pacemaker (lp) was causing ectopy after release.The lp also changed orientation and device movement was erratic consistent with interaction with the tricuspid valve.During retrieval, the lp had difficulty docking and dislodged while advancing the protective sleeve over the docking cap.The lp was successfully retrieved from the patient and implant was abandoned.Echocardiogram performed show inflammation in the right ventricle.The patient was in stable condition post-procedure.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The reported events of dislodgement and docking issue were not confirmed.The leadless pacemaker was returned for analysis.Visual inspection found no anomaly on the helix.The inner diameter of the device docking button where the bullets on the tether interact was within specification.Further analysis performed found no anomaly.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE
• 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: 18636982
• MDR Text Key: 334518539
• Report Number: 2017865-2024-03676
• Device Sequence Number: 1
• Product Code: PNJ
• 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,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP202V
• Device Lot Number: S000091266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Male