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Special Report

Product-experience reporting on endocardial defibrillation leads: a 4-year national perspective

, , , , , , , , & show all
Pages 383-388 | Published online: 09 Jan 2014

References

  • Amin MS, Ellenbogen KA. Focus on management of pacemaker and ICD advisories, recalls, and alerts. Curr. Treat. Options Cardiovasc. Med.8, 347–352 (2006).
  • Kapa S, Hyberger L, Rea RF, Hayes DL. Complication risk with pulse generator change: implications when reacting to a device advisory or recall. Pacing Clin. Electrophysiol.30, 730–733 (2007).
  • Catanchin A, Anderson L, Jones S, Ward D. When life-saving devices terminate life. J. Cardiovasc. Electrophysiol.19, 316–318 (2008).
  • Maisel WH. Pacemaker and ICD generator reliability: meta-analysis of device registries. JAMA295, 1929–1934 (2006).
  • Maisel WH, Moynahan M, Zuckerman BD et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA295, 1901–1906 (2006).
  • Auricchio A, Gropp M, Ludgate S, Vardas P, Brugada J, Priori SG; Writing committee for the European Heart Rhythm Association guidance document on cardiac rhythm management product performance. European Heart Rhythm Association guidance document on cardiac rhythm management product performance. Europace8, 313–322 (2006).
  • Maisel WH. Safety issues involving medical devices: implications of recent implantable cardioverter–defibrillator malfunctions. JAMA294, 955–958 (2005).
  • Hauser RG, Hayes DL, Epstein AE et al. Multicenter experience with failed and recalled implantable cardioverter–defibrillator pulse generators. Heart Rhythm3, 640–644 (2006).
  • Amin MS, Matchar DB, Wood MA, Ellenbogen KA. Management of recalled pacemakers and implantable cardioverter–defibrillators: a decision analysis model. JAMA296, 412–420 (2006).
  • Gould PA, Krahn AD; Canadian Heart Rhythm Society working group on device advisories. Complications associated with implantable cardioverter–defibrillator replacement in response to device advisories. JAMA295, 1907–1911 (2006).
  • Wilkoff BL. Pacemaker and ICD malfunction – an incomplete picture. JAMA295, 1944–1946 (2006).
  • Kleemann T, Becker T, Doenges K et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter–defibrillators over a period of >10 years. Circulation115, 2474–2480 (2007).
  • Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT. Early failure of a small-diameter high-voltage implantable cardioverter–defibrillator lead. Heart Rhythm4, 892–896 (2007).
  • Kenigsberg DN, Mirchandani S, Dover AN et al. Sensing failure associated with the Medtronic Sprint Fidelis defibrillator lead. J. Cardiovasc. Electrophysiol.19, 270–274 (2008).
  • Maisel WH. Increased failure rate of a polyurethane ICD lead. Pacing Clin. Electrophysiol.25, 877– 878 (2002).
  • Pratt TRH, Pulling CC, Stanton MS. Prospective device studies versus returned product analysis as a predictor of system survival. Pacing Clin. Electrophysiol.23, 1150–1155 (2000).
  • Suga C, Hayes DL, Hyberger LK, Lloyd MA. Is there an adverse outcome from abandoned pacing leads? J. Interv. Card. Electrophysiol.4, 493–499 (2000).
  • Kennergren C. A European perspective on lead extraction: part I. Heart Rhythm5, 160–162 (2008).
  • Kennergren C. A European perspective on lead extraction: part II. Heart Rhythm5, 320–323 (2008).
  • Bongiorni MG, Giannola G, Arena G et al. Pacing and implantable cardioverter–defibrillator transvenous lead extraction. Ital. Heart J.3, 261–266 (2005).
  • Neuzil P, Taborsky M, Rezek Z et al. Pacemaker and ICD lead extraction with electrosurgical dissection seaths and standard transvenous extraction systems: results of a randomized trial. Europace2, 98–104 (2007).
  • Uslan DZ, Sohail MR, St Sauver JL et al. Permanent pacemaker and implantable cardioverter defibrillator infection: a population-based study. Arch. Intern. Med.167, 669–675 (2007).
  • Verma A, Wilkoff BL. Intravascular pacemaker and defibrillator lead extraction: a state-of-the-art review. Heart Rhythm1, 739–745 (2004).
  • Byrd CL, Wilkoff BL, Love CJ et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994–1996. U.S. Extraction Database, MED Institute. Pacing Clin. Electrophysiol.9, 1348–1357 (1999).
  • Goette A, Cantu F, van Erven L et al.; Scientific Initiative Committee of the European Heart Rhythm Association. Performance and survival of transvenous defibrillation leads: need for a European data registry. Europace11(1), 31–34 (2009).
  • Ellenbogen KA, Wood MA, Shepard RK et al. Detection and management of an implantable cardioverter defibrillator lead failure: incidence and clinical implications. J. Am. Coll. Cardiol.41, 73–80 (2003).
  • Gunderson BD, Gillberg JM, Wood MA, Vijayaraman P, Shepard RK, Ellenbogen KA. Development and testing of an algorithm to detect implantable cardioverter–defibrillator lead failure. Heart Rhythm3, 155–162 (2006).
  • Møller M, Arnsbo P, Asklund M et al. Quality assessment of pacemaker implantations in Denmark. Europace4, 107–112 (2002).

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