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Implantable Rhythm Management Device Failures and Patient/Physician Notification: A Simmering Cauldron Boils Over

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References

  1. Saksena S. Calamities and Cardiac Arrhythmias: The medical and economic consequences of epidemics of suffering. J lntervent Cardiac Electrophysiology 2002;6:1–3.

    Google Scholar 

  2. Fauchier L, de Labriolle A, Babuty D. World Trade Center attack and cardiac events: Fact or fear? J Am Coll Cardiol 2005 May 17;45(10):1732–1733.

    Article  Google Scholar 

  3. Mathew P, Lewis C, Neglia J, Krol RK, Saksena S. Interaction between electronic article surveillance systems and implantable defibrillators: Insights from a fourth generation ICD. Pacing Clin Electrophysiol 1997;20:2857–2859.

    CAS  PubMed  Google Scholar 

  4. Vlay SC. Fish pond electromagnetic interference resulting in an inappropriate implantable cardioverter defibrillator shock. Pacing Clin Electrophysiol 2002;25(10):1532.

    Article  PubMed  Google Scholar 

  5. Kolb C, Schmieder S. Schmitt C. Inappropriate shock delivery due to interference between a washing machine and an implantable cardioverter defibrillator. J Interv Card Electrophysiol 2002;7(3):255–256.

    Article  PubMed  Google Scholar 

  6. Saksena S. Antiarrhythmic device advisories and recalls: Managing an increasingly vulnerable process. Pacing Clin Electrophysiol 1999;22(6 Pt 1):950–952.

    CAS  PubMed  Google Scholar 

  7. Tullo NG, Saksena S, Krol RB, Mauro AM, Kunecz D. Management of complications associated with a first-generation endocardial defibrillation lead system for implantable cardioverter-defibrillators. Am J Cardiol 1990;66:411–415.

    Article  CAS  PubMed  Google Scholar 

  8. Hauser R, Hayes D, Parsonnet V, Furman S, Epstein A, Hayes J, Saksena S, Irwin M, Almquist A, Cannom D, Gross J, Kallinen L. Feasibility and initial results of an Internet-based pacemaker an ICD Pulse generator and lead registry. Pacing Clin Electrophysiol 2001;24(1):82–87.

    Article  CAS  PubMed  Google Scholar 

  9. Saksena S. Reducing mortality in patients with advanced cardiovascular disease: Subgroups, subgroups and more subgroups. J Interv Card Electrophysiol 2004;10(1):7–8.

    Article  PubMed  Google Scholar 

  10. Armstrong PW, Bogaty P, Buller CE, Dorian P, O'Neill BJ. Canadian cardiovascular society working groupthe 2004 acc/aha guidelines: A perspective and adaptation for Canada by the Canadian Cardiovascular Society Working Group. Can J Cardiol 2004;20(11):1075–1079.

    Google Scholar 

  11. Bryant J, Brodin H, Loveman E, Payne E, Clegg A. The clinical and cost-effectiveness of implantable cardioverter defibrillators: A systematic review. Health Technol Assess 2005;9(36):1–150, iii.

    Google Scholar 

  12. Steinbrook R. Wall Street and clinical trials. N Engl J Med 2005;15;353(11):1091–1093.

    Google Scholar 

  13. Goldman BS, Newman D, Fraser J, Irwin M. Management of intracardiac device recalls: A consensus conference. Participants of the Consensus Conference. North American Society of Cardiac Pacing and Electrophysiology (NASPE) Pacing Clin Electrophysiol 1996;19(1):7–17.

    CAS  PubMed  Google Scholar 

  14. Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001;286(7):793–799.

    Article  CAS  PubMed  Google Scholar 

  15. Wilkoff BL. ICDs: Dealing with less than perfect. J Cardiovasc Electrophysiol 2005;16(7):796–797.

    Article  PubMed  Google Scholar 

  16. Hauser RG. Kallinen: Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database. Heart Rhythm 2004;1(4):399–405.

  17. Meier B. Maker of heart device kept flaw from doctors. NY Times (Print). 2005;A1:C3C3.

  18. Meier B. Implants with flaws: Disclosure and delay. NY Times 2005 Jun 14;C1.

  19. Meier B: A choice for the heart: it's easier to get data on a car than on a medical device. NY Times 2005;C1, C19.

  20. Steinbrook R. The controversy over Guidant's implantable defibrillators. N Engl J Med 2005;353(3):221–224.

    Article  CAS  PubMed  Google Scholar 

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Saksena, S. Implantable Rhythm Management Device Failures and Patient/Physician Notification: A Simmering Cauldron Boils Over. J Interv Card Electrophysiol 14, 135–137 (2005). https://doi.org/10.1007/s10840-006-6677-0

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