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Sprint Fidelis® Model 6949 Lead Performance
August 2009 Website Update
Shown here are the survival curves for the Sprint Fidelis lead model 6949 using CareLink and SLS data. The data shows 51 month survival of 95.3% [+0.5/-0.5] for CareLink data and 48 month survival of 94% [+2.0/-2.8] for SLS data.
Medtronic truncates the survival curve when the number of leads entering an interval is less than 50 leads. When the number of leads entering an interval reaches 50, the next data point is added to the survival curve. At the SLS 51 month data point, we currently have less than 50 patients.
The estimated survival probability at the leading edge of the SLS survival curve may change over time due to the limited accuracy associated with small sample sizes. Smaller study populations can artificially skew results, as small data movements in smaller samples can bring about disproportionately large percentage changes. For example, a single event in a population with an effective sample size of approximately 50 leads can change the estimated survival probability by 2%. As the implanted population ages and the sample size increases for each time interval, the accuracy of the estimated survival probability will increase as shown by tighter confidence intervals.
