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

Model Number	LSP203A
Medical Device Problem Codes	Failure to Capture (1081); Use of Device Problem (1670); Low impedance (2285)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for an initial implant procedure of an aveir leadless system on (b)(6) 2026.The ventricular leadless pacemaker (vlp) was implanted uneventfully.Upon fixating the atrial leadless pacemaker (alp), it was noted the capture thresholds were high, the pacing impedance was low, and there was no change in the current of injury.The alp was repositioned with similar measurements noted with the added side effect of no capture due to the high thresholds.The physician opted for ventricular pacing only and elected to abandon the alp.Post-procedure the patient reported symptoms of nausea, dizziness, and low blood pressure.Transthoracic echocardiogram (tte) revealed pericardial effusion in the atria with blood being localized to the area indicating a cardiac perforation.A pericardiocentesis was performed to remove the blood and the patient stabilized.No further intervention is planned.
Additional 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.

• 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: 50883333
• Report Number: 2017865-2026-20281
• Device Sequence Number: 9826624
• Product Code: PNJ
• UDI-Device Identifier: 05415067051189
• UDI-Public: (01)05415067051189(10)S000114174(17)280528
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: LSP203A
• Device Catalogue Number: LSP203A
• Device Lot Number: S000114174
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2026
• 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; Other
• Patient Sex: Female
• Patient Race: White