NeuroMAUDE
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Abbott Infinity DBS Lead

No active recall

Manufacturer: Abbott  · FDA product code: MHY  · Category: Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Severity Snapshot

549 total reports2017-052026-03 date range34.2% physician / facility reported65.8% manufacturer reported2 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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