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

Model Number LSP112V

Device Problem Failure to Interrogate (1332)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

It was reported the patient presented for implant procedure.During surgery, the leadless pacemaker exhibited a failure to interrogate over conductive telemetry.The surgery was completed with a different leadless pacemaker.The patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The reported event of failure to interrogate was confirmed.The device was unable to establish telemetry and no output was noted upon receipt.Analysis after the device was cut open revealed battery voltage was above elective replacement indicator (eri) level, which should have been capable to support telemetry.Further analysis performed on the hybrid indicated a metal migration anomaly causing a short.

• 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: 18576987
• MDR Text Key: 333698780
• Report Number: 2017865-2024-01974
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• 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: S000091991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2023
• 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 Age: 86 YR
• Patient Sex: Male
• Patient Weight: 77 KG