Optisure Adverse Events: FDA MAUDE Data

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

Total Reports

4,894

Reports (30d)

35

Active Signals

7

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Active safety signals

Disproportionate reportingmediumDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportingmediumDisproportionate reportingmedium

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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.