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VNS Therapy® Demipulse Duo® Model 104 Generator

LIVANOVA USA, INC. · Model 104 · UDI-DI 05425025750047

MUZLYJ Prescription
0
510(k) clearances
2,367
Adverse events (77 deaths)
1
Recalls
1
Facilities

Description

Implantable Pulse Generator

Recalls

DateFirmReason
2017-11-13Cyberonics, IncCertain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the misca

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.