Micra VR2 Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2023

Total Reports

833

Reports (30d)

13

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

High Threshold and Deployment Failure

implantable pulse, pulse generator, leadless implantable, generator ipg, ipg

62

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.