APPENDIX I

Performance Update for Sprint Fidelis® Leads (Models 6949, 6948, 6931, 6930)1


Sprint Fidelis Lead Survival Probability (RPA, SLS2 and CareLink Network)

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Sprint Fidelis Lead versus Quattro® Lead SLS Survival Probability

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References

1

Due to the small implant sample size of Sprint Fidelis models 6930, 6931 and 6948, the SLS, CareLink Network and RPA data are based on Sprint Fidelis 6949 leads only.

2

Since the lead survival estimate can become very imprecise with small effective sample sizes, Medtronic truncates the lead survival curve when the number of leads entering an interval is less than 50 leads.