AVEIR AR 2 Leadless Pacemaker
Received Jul 31, 2026 · Event occurred Jul 14, 2026
Report 2017865-2026-16082 · MDR key 50104274
Device
Generic name
Leadless Pacemaker
Manufacturer
Abbott Medical (crm-sylmar)Model number
LSP203ACatalog number
LSP203A
Lot number
S000113138
Product problems
- Adverse Event Without Identified Device or Use 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.