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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 ManagementRV LEAD

RV LEAD Adverse Events: FDA MAUDE Data

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

Total Reports

182

Reports (30d)

2

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

High Shock Impedance Measurements

remains service, effects, shock impedance, services, ohms

1

reports

2

Oversensed Noise on ICD Channel

implantable cardioverter, icd, cardioverter, effects, cardioverter defibrillator

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

Large PPM Lead-Associated Thrombus in a JAK2-Positive Patient.

Nelson DM, et al. · 2026

Pacemaker therapy through a sex-specific lens: a narrative review of clinical and procedural disparities.

Antoun I, et al. · 2026

Evaluation and Management Principles for Chronic Right Heart Failure and Tricuspid Regurgitation.

Sampath-Kumar R, et al. · 2025

Transjugular Transcatheter Tricuspid Valve Replacement in Patients With Cardiac Implantable Electronic Devices.

So KC, et al. · 2025

Management of Cardiac Implantable Electronic Devices in Patients With Severe Symptomatic Tricuspid Regurgitation-Proposed Algorithm and Selected Case Examples.

Kerolos MM, 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.