Micra¿ AV2
Received Jul 31, 2026 · Event occurred Jul 8, 2026
Report 9612164-2026-03860 · MDR key 50095054
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
87 YR · Female
- Cardiac Arrest
- Ventricular Fibrillation
- Loss of consciousness
- Cardiac Perforation
- Pericardial Effusion
Narrative
Description of Event or Problem
It was reported that intra operatively during the placement of the Leadless implantable pulse generator (IPG), Patient was non-responsive after the sheath was accessed and valve was crossed. Contrast injection showed Cardiac perforation. Patient coded and Echocardiogram showed Pericardial effusion. Pericardiocentesis was performed which resulted in resolving the effusion. Later, the patient experienced Ventricular Fibrillation (VF) and passed away eventually.
Additional Manufacturer Narrative
This is a system report. Section D references the main component of the system. Other medical products in use during the event include: Brand Name "[MICRA]", Product ID "[MC2AVR1-DELSYS]", (Serial: (b)(6)). Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.