Product Performance Report Q3 2014
1 / 98Pages

Cardiac Rhythm Management  //  Cumulative Survival Probability Product Performance Report July 2014 Product Performance Report  July 2014 6024 Jean Road Lake Oswego, OR 97035-05369 Tel (800) 547-0394 (24-hour) Fax (800) 291-0470 www.biotronik.com © BIOTRONIK SE & Co. KG All rights reserved. Specifications are subject to modification, revision and improvement.

Product Performance Report July 2014 Cardiac Rhythm Management Pacemakers ICDs Leads

Methodology for pacemaker and ICD survival estimates - - - - -  8 - - - Cumulative Survival Probability - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  8 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Data acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  9 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Returned product analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  10 - - - - - - - - - - - - -...

Quality excellence BIOTRONIK has a long history of high quality in product design and performance. For 50 years, the name BIOTRONIK has been synonymous with excellent workmanship and reliable patient safety. Our quality concept follows an integrated approach and extends from preventative risk mea­­ sures during a product’s development phase through all the steps of the manufacturing and design p­ ocess. r BIOTRONIK’s quality assurance system guarantees strict adherence to internal quality standards as well as compliance with international standards and guidelines. Regular reviews of our...

Because a significant portion of this report is based on analyses of returned products, ­ IOTRONIK urges B all physicians to return ­ xplanted devices and to e notify us when a product is explanted or no longer in use for any reason. BIOTRONIK aims to continually improve and enhance the scope of this report while inte­ rating the latest g information and data concerning the performance of our products. Please contact our U.S. Compliance Department (888) 345-0374 or Worldwide CRM Technical Service Department at +49-30-68905-1133 (Germany) with any comments, suggestions or questions. Your...

The following terms and definitions are used for pacemakers and Implantable Cardioverter Defibrillators (ICDs) as well as pacing and ICD leads throughout this Product Performance Report. These definitions form the basis for this Product Performance Report by clearly articulating the status of each device return and product analysis classification. Elective Replacement Indicator All active implantable devices that are powered by an internal battery need to be replaced when their battery is depleted. BIOTRONIK pacemakers and ICDs have an Elective Replacement Indicator (ERI) feature aka...

sudden malfunction during a tachycardia or fibrillation event resulting in aborted delivery of therapy; intermittent malfunction where therapy is sporadically unavailable. Malfunctions without compromised therapy The condition when a pacemaker or ICD is found to have malfunctioned in a manner that did not compromise pacing or defibrillation therapy while implanted and in service. Therapy is not compromised as long as critical patient-protective pacing and defibrillation therapies are available as determined through device analysis. Lead complications A lead performance issue where a...

3 Methodology for pacemaker and ICD survival estimates 3.1 Cumulative Survival Probability This report has been prepared in accordance with ISO 5841-2:2000 (E) applying actuarial analysis for the calculation of survival probabilities. Survival estimates given in this report are considered to be generally representative for worldwide performance of BIOTRONIK devices. In general, during the initial phase of the service time, devices which are out of specification are the primary contribution to reduction of survival probability. As the product lifecycle lengthens, normal battery depletion...

This report is based on the observation of B ­ IOTRONIK’s U.S. products through review of our device registration and tracking systems and analyses of returned products from all sources. Because the ability to perform decedent searches of patients with BIOTRONIK devices via the U.S. Social Security Administration, the use of U.S. data more accurately represents the active patient population for reporting purposes. In addition, device tracking regulations and vigilance reporting regulations vary throughout the world; therefore use of the U.S. data is most appropriate for accurate and...

3.3 Returned product analysis Information on malfunctioning for the pacemaker and ICD portions of this report is taken exclusively from the analysis of returned products. The outcome of this analysis is the basis for the final classification of the device’s cause of explantation. Only analyzed products with confirmed device malfunctions are utilized in the calculation of malfunction-free survival probability. Every pacemaker and ICD returned to ­ IOTRONIK is B analyzed per internal procedures and classified as functioning normally, normal battery depletion, or malfunctioning (including...

3.4 Product performance graphs and data The product performance information is shown in each section in alphabetical order and by product type. For each product, the report provides:   Product versions that contribute to the ­ valuation e   U.S. and CE market release dates   Worldwide quantity of products that have been distributed   U.S. registered implants (number of products included in this report)   Estimated active U.S. implants  Number of U.S. normal battery depletions  Number of U.S. confirmed malfunctions The survival plots provide: 1.  Total survival The combined Cumulative...

Performance of BIOTRONIK pacemakers