Micra¿ AV2
Received Jul 31, 2026 · Event occurred Jun 26, 2026
Report 9612164-2026-03862 · MDR key 50095753
Device
Product problems
- Migration or Expulsion of Device
- Device Dislodged or Dislocated
Patient
Not reported
- Pulmonary Embolism
- Unspecified Infection
Narrative
Description of Event or Problem
It was reported that the Leadless implantable pulse generator (IPG) dislodged resulting in threshold increase. The dislodgement resulted in the device migrating towards pulmonary artery. It was believed that the dislodgement was due to infection. The leadless IPG was removed. No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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.