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Medtronic Infinity DBS Flex Extn Kit
No active recall
Manufacturer: Medtronic · FDA product code: MHY · Category: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Severity Snapshot
1,205 total reports2017-05 – 2026-03 date range72.3% physician / facility reported27.7% manufacturer reported2 SKU variants
Failure & Consequence Profiles
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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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