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

Model Number LSP201A

Device Problems Separation Failure (2547); Connection Problem (2900); Impedance Problem (2950)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2024-34032.It was reported that post-implant, the patient's atrial leadless pacemaker (lp) was capturing intermittently and was causing muscle stimulation in the patient.X-ray confirmed dislodgement of the lp.During the revision procedure, it was found that the replacement lp exhibited issues in fully docking to the catheter and the catheter failed to go into tether mode resulting in separation failure by the lp.The impedance was also noted to be unstable.The procedure was completed using a third lp on 14 feb 2024.The patient was stable.

Manufacturer Narrative

The reported events of impedance problem, separation failure and connection problem were not confirmed.Final analysis found that the outer helix was within specification and electrical features including telemetry and impedance measurements were without any anomalies.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.

• 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: 18833052
• MDR Text Key: 337071036
• Report Number: 2017865-2024-34033
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP201A
• Device Lot Number: S000091825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• 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: 88 YR
• Patient Sex: Male
• Patient Weight: 72 KG