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); Under-Sensing (1661); Device Dislodged or Dislocated (2923)

Patient Problem Embolism/Embolus (4438)

Event Date 02/16/2024

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for a follow-up.Upon interrogation, it was noted that the leadless pacemaker (lp) exhibited undersensing and loss of capture.A chest x-ray was performed and confirmed the lp dislodged to the pulmonary artery.The lp was explanted but and was replaced with a dual chamber intravenous pacemaker three days later.During explant, it was noted the lp helix had stretched.The patient was stable.

Manufacturer Narrative

The reported event of stretched helix was confirmed.The reported event of under sensing, failure to capture, and dislodgement were not confirmed.Final analysis found blood and that the helix was stretched out of specification.The helix elongation is consistent with having occurred during procedure.Further analysis performed found no anomalies contributing to reported event of sensing or capturing problem.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• 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: 18852293
• MDR Text Key: 337069047
• Report Number: 2017865-2024-34290
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067034472
• UDI-Public: 05415067034472
• 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,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: S000090717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male