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

Model Number	LSP203A
Medical Device Problem Codes	Stretched (1601); Use of Device Problem (1670); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an initial implant procedure of an atrial leadless pacemaker (alp) on (b)(6) 2026.Upon fixation, the current of injury and capture thresholds were unacceptable and the physician elected to reposition the alp at which time it was noted the helix stretched.The alp was not used, and a new alp was successfully implanted.The patient was stable throughout the procedure.
Event or Problem Description
Additional information received indicated the alp lost capture at 0.1 milliseconds (ms) pulse width and had intermittent capture at 1.5 ms pulse width.While trying to retrieve the alp to reposition it, it was noted the alp would not dock.Advance maneuvers were used and the entire system was retrieved without issue.

• 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: 50916112
• Report Number: 2017865-2026-20512
• Device Sequence Number: 5778086
• Product Code: PNJ
• UDI-Device Identifier: 05415067051189
• UDI-Public: (01)05415067051189(10)S000115252(17)280803
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LSP203A
• Device Catalogue Number: LSP203A
• Device Lot Number: S000115252
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2026
• 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
• Patient Sex: Male
• Patient Weight: 185 LB