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Proclaim 5 Elite
No active recall
FDA product code: LGW · Category: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Severity Snapshot
15,773 total reports2017-01 – 2026-03 date range93% physician / facility reported7% 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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