Letter from the Vice President
Advancing Science for Life
For over forty years, meaningful innovation at Boston Scientific Rhythm Management has helped patients live healthier, longer lives. We are committed to providing performance data which are accurate, transparent and responsive to topics of contemporary clinical interest. This Q4 2016 report includes data through October 10, 2016.
Boston Scientific provides performance data for pulse generators and leads that meets or exceeds the 2014 revision of ISO 5841-2: 2014 (E), the AdvaMed Industry Guidance for Uniform Reporting of Clinical Performance, and addresses recommendations from the Heart Rhythm Society Task Force.
This report provides the most comprehensive presentation of CRM product performance data available, including:
- U.S. lead and pulse generator survival probability
- Worldwide malfunction counts and patterns
- Worldwide malfunctions during an implant procedure
- Longitudinal Surveillance Registry lead survival probability
- Acute (first month) lead observations
- Chronic (after first month) lead complications
- Reasons for out of service
- Return rates
Your feedback is always welcome, and plays a vital role in our effort to continuously improve our products and services, advancing science to transform the lives of our patients.
Renold J. Russie
Vice President, Quality Assurance