MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) AVEIR AR 2 Leadless Pacemaker

Model Number	LSP203A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient presented for follow-up with dyspnea.Chest x-ray confirmed a left pleural effusion associated with the implant of the atrial and ventricular leadless pacemaker (lp).A pleural drainage was performed.The pleural effusion improved and the patient was discharged.

• Brand Name: AVEIR AR 2 Leadless Pacemaker
• Common Device Name: Leadless Pacemaker
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50899640
• Report Number: 2017865-2026-20380
• Device Sequence Number: 20333761
• Product Code: PNJ
• UDI-Device Identifier: 05415067051189
• UDI-Public: (01)05415067051189
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P150035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: LSP203A
• Device Catalogue Number: LSP203A
• Device Lot Number: S000111071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 123 LB