NeuroMAUDE
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Medtronic Stealthstation I7

No active recall

Manufacturer: Medtronic  · FDA product code: HAW  · Category: Neurological Stereotaxic Instrument

Severity Snapshot

421 total reports2011-042025-05 date range5% physician / facility reported95% 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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