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Wavewriter Alpha 16
No active recall
FDA product code: LGW · Category: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Severity Snapshot
1,341 total reports2021-01 – 2026-03 date range95.9% physician / facility reported4.1% manufacturer reported1 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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