Back to Boston Scientific
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
Click any bar to view those reports ↓
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.
Loading reports…