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

Model Number LSP202V

Device Problems Failure to Capture (1081); Under-Sensing (1661); Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)

Patient Problem Embolism/Embolus (4438)

Event Type  Injury  

Event Description

It was reported that the patient presented for aveir leadless pacemaker (lp) implant.During the procedure, it was found that the right ventricular lp exhibited difficulty in separating from the delivery catheter.The lp was eventually fixed.During post-implant check, it was noted that the device was failing to capture and exhibited signal under-sensing.X-ray revealed the lp had dislodged and traveled outside the intended chamber.The lp was retrieved and replaced.The patient was stable.

• 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: 19154683
• MDR Text Key: 340737144
• Report Number: 2017865-2024-39278
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067040725
• UDI-Public: (01)05415067040725(10)S000091786(17)240922
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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: S000091786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2023
• 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: 86 YR
• Patient Sex: Male