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

Model Number LSP112V

Device Problems Failure to Capture (1081); Stretched (1601)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported the patient presented for implant procedure.During surgery, the leadless pacemaker (lp) was fixated but was unable to capture the right ventricle.While attempting to reposition the lp, the helix extended.The procedure was completed with a different lp.There were no patient consequences.

• 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: 18692399
• MDR Text Key: 335214116
• Report Number: 2017865-2024-22439
• Device Sequence Number: 1
• Product Code: PNJ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P150035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP112V
• Device Lot Number: S000091555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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