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

Model Number LSP202V

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

Patient Problem Embolism/Embolus (4438)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that at discharge check, the patient's right ventricular leadless pacemaker (rv lp) exhibited failure to sense and failure to capture.Chest x-ray revealed the rv lp had dislodged into the hepatic vein.The device was successfully retrieved and replaced.The patient was stable.

Manufacturer Narrative

The reported events of post-op dislodgement, failure to capture and failure to sense could not be confirmed.Final analysis found the helix length was within specification.A device history record (dhr) review was performed.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.No anomalies were detected.

• 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: 18969224
• MDR Text Key: 338496709
• Report Number: 2017865-2024-35791
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067040725
• UDI-Public: 05415067040725
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP202V
• Device Lot Number: S000091824
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2023
• 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: ATRIAL LEADLESS PACEMAKER
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female