International Journal of Cardiology
Volume 134, Issue 1 , Pages 42-46 , 1 May 2009

Complications of replacing implantable devices in response to advisories: A single center experience

Received 24 September 2007 ,Revised 17 December 2007 ,Accepted 26 December 2007.

References 

  1. Mond HG, Irwin M, Morillo C, Ector H. The world survey of cardiac pacing and cardioverter defibrillators: calendar year 2001. Pacing Clin Electrophysiol. 2004;27:955–964
  2. Seidl K, Senges J. Worldwide utilization of implantable cardioverter/defibrillators now and in the future. Card Electrophysiol Rev. 2003;7:5–13
  3. Maisel WH. Pacemaker and ICD generator reliability: meta-analysis of device registries. JAMA. 2006;295:1929–1934
  4. Carlson MD, Wilkoff BL, Maisel WH, et al. American College of Cardiology Foundation, American Heart Association, International Coalition of Pacing and Electrophysiology Organizations. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm. 2006;3:1250–1273
  5. Gould PA, Krahn AD. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA. 2006;295:1907–1911
  6. Al-Khatib SM, Lucas FL, Jollis JG, Malenka DJ, Wennberg DE. The relation between patients' outcomes and the volume of cardioverter-defibrillator implantation procedures performed by physicians treating Medicare beneficiaries. J Am Coll Cardiol. 2005;46:1536–1540[Erratum in J Am Coll Cardiol 2005;46:1964]
  7. Class 1 Medical Device Recalls- Micro Jewel II and GEM DR ICDs. Available at: http://www.fda.gov/cdrh/recalls/recall-040404.html. Accessibiliy verified April 4, 2007.
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  9. Class 1 Medical Device Recalls – Ventak Prizm 2 RD ICDs. Available at: http://www.fda.gov/cdrh/recalls/recall-062905b.html. Accessibiliy verified April 4, 2007.
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  13. Urgent Medical Device Safety Information & Corrective Action: Re: Guidant INSIGNIA® and NEXUS® implantable heart pacemakers. Available at: http://www.guidant.com/physician_communications/insignia-nexus.pdf. Accessibility verified April 4, 2007.
  14. Wilkoff BL. Pacemaker and ICD malfunction—an incomplete picture. JAMA. 2006;295:1944–1946
  15. Hauser RG, Hayes DL, Epstein AE, et al. Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators. Heart Rhythm. 2006;3:640–644
  16. Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA. 2001;286:793–799
  17. Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration Annual Reports. JAMA. 2006;295:1901–1906
  18. Amin MS, Matchar DB, Wood MA, Ellenbogen KA. Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model. JAMA. 2006;296:412–420

PII: S0167-5273(08)00125-3

doi: 10.1016/j.ijcard.2007.12.070

International Journal of Cardiology
Volume 134, Issue 1 , Pages 42-46 , 1 May 2009

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