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

Model Number LSP201A

Device Problems Failure to Capture (1081); Low impedance (2285); Device Sensing Problem (2917)

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

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported the patient presented in clinic for follow-up.Upon interrogation, it was discovered the leadless pacemaker (lp) exhibited decreased pacing impedance, decreased p-wave amplitude sensing, and increased capture thresholds that resulting in loss of capture.Programming changes were implemented.The patient was in stable condition.

Event Description

New information noted the leadless pacemaker was explanted and replaced.

Manufacturer Narrative

The reported event of low impedance, sensing problem, and failure to capture were not confirmed.The leadless pacemaker was returned for analysis.Visual inspection of the device found no anomaly on outer and inner helix, helix lengths were within specification.Further analysis performed found no anomalies contributing to reported event of impedance, sensing, or capture problem.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM
• 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: 18899778
• MDR Text Key: 337622238
• Report Number: 2017865-2024-34955
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067040701
• UDI-Public: 05415067040701
• 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,Followup
• Report Date: 06/18/2024

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: LSP201A
• Device Lot Number: S000091692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 05/17/2024; 06/11/2024
• Supplement Dates FDA Received: 06/06/2024; 06/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• 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: 41 YR
• Patient Sex: Male