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Company Medtronic / / Country United States / / Currency pence / / Event FDA Phase / / IndustryTerm postmarket medical device / magnetic resonance imaging / insertion site / fluoroscopy/imaging studies / reported medical device / media attention / / MedicalCondition Arrhythmia / progressive non-cardiac disease / conduit dysfunction / congestive heart failure / pulmonary regurgitation AND No RVOT conduit reoperation / Endocarditis/infection / serious injury / One injury / severe pulmonary regurgitation OR / endocarditis / Transcatheter Pulmonary Valve / Primary endpoint TPV dysfunction / Pulmonary artery *PV/RV / atrial fibrillation / infection / Pulmonary valve/Right ventricle *RVOT / TPV dysfunction / dysfunction OR / pulmonary valve *VSD / Hemodynamic dysfunction / Pulmonary artery / serious injuries / pulmonary regurgitation / greater pulmonary regurgitation / / MedicalTreatment balloon catheter / catheter / angioplasty / cardioversion / surgery / / Organization FDA’s Division of Epidemiology / Food and Drug Administration / Center for Devices and Radiological Health / New York Heart Association / FDA’s MAUDE / FDA / TPV PAC / / Person Death Injury / / Position Executive / Major / representative / / Product MDRs / H080002 / Melody / / Technology laser / X-ray / magnetic resonance imaging / 2 PROTOCOLS / pdf / / URL http / SocialTag 
Microsoft Word - FDA Executive Summary MDR Melody TPV HDE H080002FINAL CLEARED_26 (4).doc