MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Delivery Catheter; Leadless Pacemaker

Model Number	LSCD201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a history of atrial fibrillation (af).The patient underwent a dual chamber leadless pacemaker (lp) system implant.The right ventricular lp was implanted without issue.The patient then developed af during atrial lp placement.Medicinal intervention, in the form of pilsicainide hydrochloride hydrate, was administered to the patient.However, the af persisted and made implant of the atrial lp difficult.The physician elected to abandon the atrial lp implant and continue with only the ventricular lp implanted.A second dose of pilsicainide hydrochloride hydrate was administered, but af still continued.Physician elected to not move forward with any further interventions.Patient had no other consequences.

• Brand Name: Aveir¿ Delivery Catheter
• 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: 50510236
• Report Number: 2017865-2026-18239
• Device Sequence Number: 10675367
• Product Code: PNJ
• UDI-Device Identifier: 05415067038487
• UDI-Public: (01)05415067038487(10)11383703(17)270630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/28/2026

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: LSCD201
• Device Catalogue Number: LSCD201
• Device Lot Number: 11383703
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2026
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 88 LB