MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Leadless Pacemaker, Right Atrium

Model Number	LSP201A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, it was difficult to advance the introducer smoothly into the inferior vena cava.The physician felt it was too stiff.While advancing the introducer, the patient experienced a vasovagal reaction with hypotension.The physician attempted the leadless pacemaker implant; however, the delivery catheter could not be placed in the target location as the docking button and docking cap separated and forward pressure could not be applied.Medication was administered to address the vasovagal reaction and the procedure was aborted.There were no patient consequences and the patient was stable.

• Brand Name: Aveir¿ Leadless Pacemaker, Right Atrium
• 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: 50869965
• Report Number: 2017865-2026-20196
• Device Sequence Number: 10715669
• Product Code: PNJ
• UDI-Device Identifier: 05415067040701
• UDI-Public: (01)05415067040701(10)S000109800(17)261117
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P150035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LSP201A
• Device Lot Number: S000109800
• 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: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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 Sex: Unknown