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

Model Number	LSP202V
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient presented for implant procedure.During surgery, the ventricular leadless pacemaker (lp) exhibited high impedance and capture threshold during mapping.The lp was removed for inspection and prematurely separated from delivery catheter outside the patient.The helix on the lp was also stretched and bent upon inspection.The delivery catheter and lp were replaced to complete the procedure.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: 50951000
• Report Number: 2017865-2026-20748
• Device Sequence Number: 10446407
• Product Code: PNJ
• UDI-Device Identifier: 05415067040725
• UDI-Public: (01)05415067040725(10)S000115022(17)280715
• Combination Product (Y/N): Y
• 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): 09/30/2026

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: LSP202V
• Device Lot Number: S000115022
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2026
• 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: 73 YR
• Patient Sex: Male