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Sprint Fidelis Lead Performance
May 2013 Website Update
Sprint Fidelis® Model 6949 Lead Performance
Sprint Fidelis® Model 6949 Center Fracture Data
Sprint Fidelis® Model 6931 Lead Performance
Sprint Fidelis® Model 6948 Lead Performance
∗The Sprint Fidelis lead performance is updated every 6 months.
Medtronic strives to monitor product performance as accurately as possible. In May 2009, Medtronic started using the CareLink PLUS curve to follow Fidelis performance. CareLink PLUS is a fracture based curve that includes data from CareLink transmissions PLUS returned product and save-to-disk analysis. Medtronic believes CareLink PLUS is the best representation of Fidelis lead fractures available. Below is a definition of both the numerator and denominator used to create CareLink PLUS survival curves.
| CareLink® PLUS | |
| Numerator |
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| Denominator |
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An SLS survival curve is also shown for Models 6949 and 6931. This curve includes all lead related complications, including fractures. The System Longevity Study is a prospective, multicenter, global post market clinic study. The SLS curve is truncated when the sample size of leads in that interval is less than 50. The survival for Model 6948 is only tracked with the CareLink® PLUS curve, as the SLS study for 6948 does not have enough leads enrolled to create a survival curve.
Also shown is a breakdown of our 6949 CareLink PLUS data by center. Data from 1,006 centers is used to create the Model 6949 CareLink PLUS curve. The top and bottom 5% curves illustrate the range of fractures that exist within the CareLink PLUS dataset. A minimum of 10 implants per center was required for inclusion in this analysis. 440 centers met this requirement, as such, there are 22 centers in the top and bottom 5% curves.
Lead Performance Information
Since the October 15, 2007 communication about the Sprint Fidelis family of leads, Medtronic and the Independent Physician Quality Panel have continued to analyze performance data from the Medtronic System Longevity Study (SLS) and the Medtronic CareLink Network, as well as third party data. The tables below show lead survival data and reported outcomes from third party publications (case studies and editorials were excluded).
