LEAD Adverse Events: FDA MAUDE Data

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

Total Reports

481

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Noise Oversensing Resulting in Bradycardia

noise, crt, adverse, remains service, effects

reports

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

Evidence

Related research

Comparative Analysis of Extraction Complications in Transvenous Versus Leadless Pacemakers.

Sahyouni A, et al. · Cureus · 2026

Indication-stratified early outcomes after transvenous lead extraction in hemodialysis patients: Analysis of a prospective 1256-patient registry.

Shah KB, et al. · Heart rhythm O2 · 2026

Transvenous Lead Extraction Using Mechanical Rotational Dilator Sheaths: A 19-Year Single-Center Experience from a Pediatric Cardiology Center.

Aykan HH, et al. · Journal of cardiovascular development and disease · 2026

Leadless atrial versus transvenous pacing for sinus node dysfunction: 1-year outcomes from the leadless ARRIVE real-world study.

Nilsson KR, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 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.