Medtronic Sprint Fidelis lead recall | 合法醫療器材資訊網

由AKMehrotra著作·2011·被引用15次—TheindustrystandardrateofleadfailurewasestimatedbasedontheSprintQuattromodel6947lead,andthiswassubtractedfromtheestimatedratesforthe​ ...

Background: The Medtronic Sprint Fidelis defibrillator lead has a high failure rate and was recalled in October 2007.

Objective: The purpose of this study was to determine the incremental cost of the management of this lead to Medicare.

Methods: Real hospital cost data in U.S. dollars were collected on 32 patients with a Medtronic Sprint Fidelis lead who underwent lead revision. Of these patients, 15 were excluded because they had insurance coverage other than that provided by the Centers for Medicare & Medicaid Services. Seventeen patients with Medicare or Medicaid coverage underwent lead revision either electively (n = 6) or after being hospitalized for multiple shocks caused by a lead fracture (n = 11). Eighty-eight percent of the patients underwent extraction of the Fidelis lead at the time of lead revision. A decision model was made that outlines the potential management of the...