Letter from the Vice President

Advancing Science for Life

Boston Scientific is committed to helping patients live healthier, longer lives. As part of that commitment, we provide detailed product performance data, which are accurate, transparent, and of clinical interest.

Boston Scientific Rhythm Management 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. The performance data also addresses recommendations from the Heart Rhythm Society Task Force.

The Q2 2019 report includes data through April 15, 2019. This report provides a comprehensive presentation of rhythm management product performance data available to us, including:

  • U.S. lead and pulse generator survival probability 
  • Worldwide malfunction counts and patterns 
  • Worldwide malfunctions during an implant procedure
  • 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.

Sincerely,

Renold J. Russie

Vice President, Quality Assurance

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