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

Model Number	LSP202V
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a right ventricular (rv) leadless pacemaker (lp) was implanted successfully.Physician then had difficulty inserting the right atrial (ra) lp through the delivery catheter.An x-ray revealed the rv lp had dislodged and traveled into the inferior vena cava, blocking the ra lp from advancing.The rv lp was retrieved and replaced.Patient was stable.

• 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: 50927054
• Report Number: 2017865-2026-20556
• Device Sequence Number: 10725259
• Product Code: PNJ
• UDI-Device Identifier: 05415067040725
• UDI-Public: (01)05415067040725(10)S000113250(17)280421
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: LSP202V
• Device Lot Number: S000113250
• 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: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2026
• 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: 51 YR
• Patient Sex: Male