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

Model Number	LSP203A
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Stretched (1601); Use of Device Problem (1670); Low impedance (2285); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, the device was difficult to maintain in contact with the tissue during fixation.Once fixated, it exhibited inadequate current of injury and low pacing impedance.While attempting to re-position it was difficult to re-dock the device into the delivery catheter, however, the physician eventually was able to unfix and retrieve.Upon inspection outside of the patient's body, the device's helix was noted to be sprung.The device was not used, and a new one was implanted.The patient was stable.

• 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: 50870154
• Report Number: 2017865-2026-20201
• Device Sequence Number: 9314620
• Product Code: PNJ
• UDI-Device Identifier: 05415067051189
• UDI-Public: (01)05415067051189(10)S000113140(17)280416
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/23/2026

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: S000113140
• 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: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2026
• 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 Age: 33 YR
• Patient Sex: Male