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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Cardiac Rhythm Management
MAUDE LookupCardiac Rhythm ManagementRA LEAD

RA LEAD Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)

Total Reports

192

Reports (30d)

5

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Noisy Signals and Low Impedance in Atrial Lead

adverse, effects, reported right, range, service

4

reports

2

High Impedance Triggering Polarity Switch

impedance, switch, polarity, leads, low

1

reports

3

Infection Leading to Lead Explant

lead explanted, infection, revision, effects, additional adverse

1

reports

4

Lead Abandoned Due to Performance Issues

chest, effects, reported right, service, additional adverse

1

reports

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

Detection

Active safety signals

Disproportionate reportingmedium

Evidence

Related research

From Failure to Success: Lithotripsy Transforms Lead Extraction in a Same-Patient Case.

Goldar G, et al. · 2025

Cardiac implantable electronic device carriers undergoing transcatheter tricuspid valve annuloplasty: real-world insights.

Wrobel JM, et al. · 2025

Recent Advances in Cardiac Resynchronization Therapy: Current Treatment and Future Direction.

Siddiqui A, et al. · 2025

Left Bundle Branch Area Pacing in Cardiac Resynchronization Therapy: How Does It Compare to Biventricular Pacing in Terms of Electrocardiographic Parameters and Procedural Outcomes?

Atabekov T, et al. · 2025

Pacemaker pocket histoplasmosis - A rarest of rare CIED infection.

Dar MI, et al. · 2026

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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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.