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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 ManagementLEAD

LEAD Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Permanent Pacemaker Electrode (Lead)

Total Reports

480

Reports (30d)

0

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Evidence

Related research

Safety and Clinical Outcomes of Transvenous Lead Extraction for Cardiac Device Infections in the Very Elderly.

Sawalha K, et al. · 2025

Safety Outcomes of Hybrid Open Chest Transvenous Lead Extraction: A Multicenter Experience.

Wijesuriya N, et al. · 2025

Era of Synchronized Physiologic Leadless Pacing: A Novel Approach to Cardiac Pacing and Ongoing Development.

Shrestha DB, et al. · 2026

Physiologic Predictors of Postoperative Dialysis After Total Knee Arthroplasty.

Piquion S, et al. · 2026

Impact of Transvalvular Cardiac Implantable Electronic Devices on Outcomes Following Tricuspid Transcatheter Edge-to-Edge Repair.

Zahid S, et al. · 2025

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.