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

Model Number LSP112V

Device Problems Failure to Interrogate (1332); Premature Separation (4045)

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

Event Date 04/06/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-18631.It was reported the patient presented for a leadless pacemaker implant.During the procedure it was observed the leadless pacemaker lost telemetry when test functions were initiated, or programming was attempted.After an hour of troubleshooting and no successful connection, it was observed the leadless pacemaker spontaneously released from the delivery catheter but remained attached to the tissue.The leadless device remained implanted, and a conventional pacemaker was also implanted without issue.There were no adverse consequences to the patient.

Manufacturer Narrative

The reported complaint of loss of telemetry was confirmed via analysis of the merlin log.The analysis determined that the root cause of the inability to establish telemetry was due to insufficient strength of the received telemetry signal from the lp.The cause of the insufficient strength could not be determined, although the available evidence strongly rules out any defect with the lp, link module, or merlin programmer.

• 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: 16826278
• MDR Text Key: 314121989
• Report Number: 2017865-2023-18627
• 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,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: LSP112V
• Device Catalogue Number: LSP112V
• Device Lot Number: S000087755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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 Age: 93 YR
• Patient Sex: Female
• Patient Weight: 102 KG