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Optisure Lead Post Approval Study

The following objectives will be evaluated in the post approval study: 1. To determine the Optisure lead related complication free rate at 5 years 2. To document all Optisure lead related adverse events Additionally, the following objectives will be evaluated in a subset of patients in the Optisure lead study who agree to participate in a sub-study: 1. To determine the incidence of externalized conductors after enrollment 2. To determine the incidence of other visual lead anomalies by each subcategory per Appendix A after enrollment 3. To determine the incidence of electrical dysfunction§ after enrollment 4. To evaluate the 30-day adverse event rate associated with lead revision procedures (include lead extractions or abandonments with or without lead replacement) 5. To determine the prevalence of other insulation anomalies in returned Optisure leads: Internal abrasion short under RV shock coil Internal abrasion short under SVC shock coil Exposed conductors defined as a breach of the outer insulation and/or breach of the internal silicone lumen tubing, but the conductor cable is contained within the lead body diameter. Electrical dysfunction is determined to be present after adjudication of the following cases of potential electrical failures that led to the lead being either surgically capped/extracted or electrically abandoned. Potential electrical failures include the following: Presence of non-physiologic noise not due to external interference Rise in pace/sense (p/s) conductor impedance to greater than 2000 ohms or increase of more than 200 ohms over previous 6 months or increase of 400 ohms; over any period of time Decrease of more than 200 ohms over previous 6 months or to impedance less than 200 ohms from baseline impedance greater than 300 ohms or decrease of 400 ohms; over any period of time Change in any high voltage coil impedance of greater than 25 ohms or to greater than 125 ohms or less than 20 ohms. Capture threshold greater than 5 V or an increase of greater than 2 V from baseline (all measurements) of less than 1 V NOTE: In all cases, external sources of noise and other headerconnector causes would be excluded. Functional abnormalities, including exit block and physiologic oversensing in the presence of an electrically intact lead are not electrical failures.

The following objectives will be evaluated in the post approval study: 1. To determine the Optisure lead related complication free rate at 5 years 2. To document all Optisure lead related adverse events Additionally, the following objectives will be evaluated in a subset of patients in the Optisure lead study who agree to participate in a sub-study: 1. To determine the incidence of externalized conductors after enrollment 2. To determine the incidence of other visual lead anomalies by each subcategory per Appendix A after enrollment 3. To determine the incidence of electrical dysfunction§ after enrollment 4. To evaluate the 30-day adverse event rate associated with lead revision procedures (include lead extractions or abandonments with or without lead replacement) 5. To determine the prevalence of other insulation anomalies in returned Optisure leads: Internal abrasion short under RV shock coil Internal abrasion short under SVC shock coil Exposed conductors defined as a breach of the outer insulation and/or breach of the internal silicone lumen tubing, but the conductor cable is contained within the lead body diameter. Electrical dysfunction is determined to be present after adjudication of the following cases of potential electrical failures that led to the lead being either surgically capped/extracted or electrically abandoned. Potential electrical failures include the following: Presence of non-physiologic noise not due to external interference Rise in pace/sense (p/s) conductor impedance to greater than 2000 ohms or increase of more than 200 ohms over previous 6 months or increase of 400 ohms; over any period of time Decrease of more than 200 ohms over previous 6 months or to impedance less than 200 ohms from baseline impedance greater than 300 ohms or decrease of 400 ohms; over any period of time Change in any high voltage coil impedance of greater than 25 ohms or to greater than 125 ohms or less than 20 ohms. Capture threshold greater than 5 V or an increase of greater than 2 V from baseline (all measurements) of less than 1 V NOTE: In all cases, external sources of noise and other headerconnector causes would be excluded. Functional abnormalities, including exit block and physiologic oversensing in the presence of an electrically intact lead are not electrical failures.