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Medtronic Bipol Lead
No active recall
Manufacturer: Medtronic · FDA product code: LYJ · Category: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Severity Snapshot
2,125 total reports2006-04 – 2026-03 date range5.5% physician / facility reported94.5% manufacturer reported3 SKU variants
Failure & Consequence Profiles
Top Failure Modes
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Top Patient Outcomes
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Reporting Trend
Annual Reporting Volume
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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.
Reported Events
Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.
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