Key result
The Medtronic Sprint Fidelis ICD lead was voluntarily recalled after 38 months on the U.S. market and 268,000 implantations worldwide because of its propensity to fracture.
Population
Patients receiving the Medtronic Sprint Fidelis implantable cardioverter-defibrillator lead
Design
Editorial
Authors
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The recall of the Sprint Fidelis ICD lead highlights the risks of FDA device approval based solely on bench testing without human clinical data.
The recall of the Sprint Fidelis ICD lead highlights the risks of FDA device approval based solely on bench testing without human clinical data.
William H. Maisel (2008) conducted an editorial in Implantable cardioverter-defibrillator (ICD) indication (n=268,000). Medtronic Sprint Fidelis ICD lead was evaluated on Lead fracture. The Medtronic Sprint Fidelis ICD lead was voluntarily recalled after 38 months on the U.S. market and 268,000 implantations worldwide because of its propensity to fracture.
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