ATRIAL LEAD Adverse Events: FDA MAUDE Data

UNKNOWN · Permanent Pacemaker Electrode (Lead) · First cleared Sep 2000

Total Reports

116

Reports (30d)

4

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Atrial Noise with Out-of-Range High Impedance

adverse, impedance, effects, range, service

3

reports

2

Lead Explant During Infection Revision

adverse, infection, effects, revision, implantable

1

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.