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

Model Number	LSP112V
Medical Device Problem Codes	Stretched (1601); Use of Device Problem (1670); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for initial implant procedure on (b)(6) 2026.Post fixation during procedure, the right ventricular (rv) leadless pacemaker (lp) exhibited no increase in pacing impedance and little to none current of injury.Repositioning was attempted, and the rvlp helix was noted to be sprung under fluoroscopy imaging.The rvlp was not implanted, and an alternate rvlp was implanted instead.There were no patient consequences.

• Brand Name: Aveir¿ Leadless Pacemaker, Right Ventricle
• 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: 50797300
• Report Number: 2017865-2026-19724
• Device Sequence Number: 18769484
• Product Code: PNJ
• UDI-Device Identifier: 05415067034472
• UDI-Public: (01)05415067034472(10)S000109047(17)271027
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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): 09/16/2026

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: LSP112V
• Device Lot Number: S000109047
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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
• Patient Sex: Unknown