Literature DB >> 22332951

Here we go again--another failure of postmarketing device surveillance.

Robert G Hauser1.   

Abstract

Mesh:

Year:  2012        PMID: 22332951     DOI: 10.1056/NEJMp1114695

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


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  22 in total

1.  [Annual report 2013 of the German Cardiac Pacemaker And Defibrillator Register--Part 2: implantable cardioverter-defibrillators. Pacemaker and AQUA Institute for Applied Quality Improvement and Research in Health Care GmbH workgroup].

Authors:  A Markewitz
Journal:  Herzschrittmacherther Elektrophysiol       Date:  2015-12

Review 2.  Considerations for cardiac device lead extraction.

Authors:  Oussama Wazni; Bruce L Wilkoff
Journal:  Nat Rev Cardiol       Date:  2016-01-29       Impact factor: 32.419

3.  Regulation of medical devices used in diabetology in Europe: time for reform?

Authors:  A J M Boulton; S Del Prato
Journal:  Diabetologia       Date:  2012-05-16       Impact factor: 10.122

4.  [Annual Report 2011 of the German pacemaker and defibrillator register: Section pacemakers and AQUA-Institute for Applied Quality Improvement and Research in Health Care].

Authors:  A Markewitz
Journal:  Herzschrittmacherther Elektrophysiol       Date:  2013-12

5. 

Authors:  A Markewitz
Journal:  Herzschrittmacherther Elektrophysiol       Date:  2017-03

6.  Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

Authors:  Joseph S Ross; Jonathan Bates; Craig S Parzynski; Joseph G Akar; Jeptha P Curtis; Nihar R Desai; James V Freeman; Ginger M Gamble; Richard Kuntz; Shu-Xia Li; Danica Marinac-Dabic; Frederick A Masoudi; Sharon-Lise T Normand; Isuru Ranasinghe; Richard E Shaw; Harlan M Krumholz
Journal:  Med Devices (Auckl)       Date:  2017-08-16

7.  Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures.

Authors:  Frederic S Resnic; Arjun Majithia; Sanket S Dhruva; Henry Ssemaganda; Susan Robbins; Danica Marinac-Dabic; Kathleen Hewitt; Lucila Ohno-Machado; Matthew R Reynolds; Michael E Matheny
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2020-04-14

8.  Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.

Authors:  Daniel B Kramer; Yongtian T Tan; Chiaki Sato; Aron S Kesselheim
Journal:  Food Drug Law J       Date:  2014       Impact factor: 0.619

9.  Increasing lead burden correlates with externalized cables during systematic fluoroscopic screening of Riata leads.

Authors:  Liza P Moorman; J Randall Moorman; John P DiMarco; Rohit Malhotra; Andrew Darby; Kenneth Bilchick; John D Ferguson; J Michael Mangrum; Sandeep Kamath; Pamela K Mason
Journal:  J Interv Card Electrophysiol       Date:  2012-12-20       Impact factor: 1.900

10.  [Recommendations of the Working Group of Arrhythmias of the German Society of Cardiology on the approach to patients with Riata® and Riata ST® leads (St. Jude Medical). Nucleus of the Working Group of Arrhythmias of the German Society of Cardiology].

Authors:  C W Israel; D Bänsch; D Böcker; C Butter; J Chun; I Deisenhofer; L Eckardt; J-C Geller; T Hanke; T Klingenheben; C Piorkowski; B Schumacher
Journal:  Herzschrittmacherther Elektrophysiol       Date:  2012-06
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