MAUDE Adverse Event Report: AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

Model Number LSP202V

Device Problems Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

It was reported the patient presented for implant procedure.During the device check, it was discovered the leadless pacemaker was in back up mode and was unable to be interrogated.The procedure was completed with a different leadless pacemaker.There were no patient consequences.

• Brand Name: AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE
• Type of Device: Leadless pacemaker
• MDR Report Key: 18717925
• MDR Text Key: 335550021
• Report Number: 2017865-2024-32806
• Device Sequence Number: 1
• Product Code: PNJ
• Combination Product (y/n): Y
• 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
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: S000091605
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White