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Boston Scientific Infinion 16
No active recall
Manufacturer: Boston Scientific · FDA product code: LGW · Category: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Severity Snapshot
1,049 total reports2016-08 – 2026-02 date range100% physician / facility reported0% manufacturer reported5 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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