NeuroMAUDE
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Proclaim 7 Elite

No active recall

FDA product code: LGW  · Category: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Severity Snapshot

3,797 total reports2016-112026-03 date range80.6% physician / facility reported19.4% manufacturer reported2 SKU variants

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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