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

Model Number LSP112V

Device Problems Failure to Capture (1081); Low impedance (2285); Device Dislodged or Dislocated (2923)

Patient Problem Embolism/Embolus (4438)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that the patient presented for a leadless pacemaker (lp) implant procedure.After the procedure, it was noted that the lp exhibited failure to capture and low pacing impedance.X-ray imaging was performed and confirmed the lp dislodged.The device was explanted and replaced.There were no patient consequences.

Event Description

New information received indicates that the leadless pacemaker dislodged to the inferior vena cava and then moved to the right atrium.

• 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: 18980380
• MDR Text Key: 338622633
• Report Number: 2017865-2024-36923
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067034472
• UDI-Public: 05415067034472
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP112V
• Device Lot Number: S000091529
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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: LSCD111 AVEIR DELIVERY CATHETER; LSN25501 AVEIR INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 53 KG