inforMED
InjuryPNJ

Aveir¿ Leadless Pacemaker, Right Ventricle

Received Jul 31, 2026 · Event occurred Jul 14, 2026

Report 2017865-2026-16083 · MDR key 50104278

Device

Generic name

Leadless Pacemaker

Model number

LSP202V

Lot number

S000113510

Product problems

  • Device Sensing Problem

Patient

Not reported

  • Cardiac Tamponade
  • Pericardial Effusion

Narrative

Description of Event or Problem

It was reported the patient presented for implant procedure. During surgery the ventricular Leadless Pacemaker (vLP) exhibited low R-wave amplitude sensing after fixation. The vLP was removed for inspection, tissue was removed from the helix, and successfully implanted. During implant of the atrial Leadless Pacemaker (aLP), the deflection lever on the delivery catheter was released and the catheter moved prematurely requiring slight deflection and slack to complete the implant. Post-procedure, cardiac tamponade was confirmed via echocardiogram and pericardial drainage was performed. The patient was in stable condition.