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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.

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MAUDE LookupCardiac Rhythm ManagementOptisure

Optisure Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead) · First cleared May 1996 · 32 device variants grouped

Total Reports

4,799

Reports (30d)

59

Active Signals

8

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Detection

Active safety signals

Disproportionate reportingmediumDisproportionate reportinghighDisproportionate reportingmediumDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportingmedium

Evidence

Related research

Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study.

Braghieri L, et al. · 2024

Long-term performance of single-connector (DF4) implantable defibrillator leads.

Ibrahim R, et al. · 2023

A Case of Very Early Lead Fracture in an Implantable Cardioverter‐Defibrillator: Management and Follow‐Up

Marwan Shawki, et al. · Pacing and Clinical Electrophysiology · 2024

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.