Heart Rhythm
Volume 6, Issue 5 , Pages 605-610 , May 2009

Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure

  • Robert G. Hauser, MD, FHRS

      Affiliations

    • Corresponding Author InformationAddress reprint requests and correspondence: Dr. Robert G. Hauser, Minneapolis Heart Institute, 920 East 28th Street, Suite 300, Minneapolis, Minnesota 55407
    • ,
  • David L. Hayes, MD, FHRS

Received 23 January 2009 ,Accepted 11 February 2009.

References 

  1. Hauser RG, Kallinen LM, Almquist AK, et al. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm. 2007;4:892–896
  2. Krahn AD, Champagne J, Healey JS, et al. Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Device Advisory Committee. Heart Rhythm. 2008;5:639–642
  3. Urgent Medical Device Information: Sprint Fidelis Lead Patient Management Recommendations. Minneapolis, MN: Medtronic, Inc; October 15, 2007;
  4. Product Performance Report 2008, 2nd Edition. Minneapolis, MN: Medtronic, Inc., Issue 59, p. 86.
  5. Farwell D, Green MS, Lemery R, et al. Accelerating risk of Fidelis lead fracture. Heart Rhythm. 2008;5:1375–1379
  6. Sprint Fidelis Model 6949 Lead Performance. Available at http://www.medtronic.com/product-advisories/physician/sprint-fidelis/6949-LEAD-PERFORMANCE.htm. Accessed January 7, 2009.
  7. Sprint Fidelis Lead Performance Update (Models 6949, 6948, 6931, 6930). Letter to Physicians, May 7, 2008. Available at http://www.medtronic.com/product-advisories/physician/sprint-fidelis/index.htm. Accessed January 7, 2009.
  8. Field ME, Jones SO, Epstein LM. How to select patient for lead extraction. Heart Rhythm. 2007;4:978–985
  9. Hauser R, Hayes D, Parsonnet V, et al. Feasibility and initial results of a Internet-based pacemaker and ICD pulse generator and lead registry. Pacing Clin Electrophysiol. 2001;24:82–87
  10. Dorey FJ, Korn EL. Effective sample sizes for confidence intervals for survival probabilities. Stat Med. 1987;6:679–687
  11. CRM Product Performance Report Q4 2008. Endotak Reliance G Dual Coil, Active Fixation Models 0164/0165/0166/0167/0184/0185/0186/0187. Available at http://www.bostonscientific.com/templatedata/imports/HTML/PPR/ppr/leads/surv/end_rel_g_dua_coi_act_fix_surv.shtml. Accessed January 7, 2009.
  12. Product Performance Report. Cardiac Rhythm Management. October 2008;http://www.sjm.com/_MediaAssets/documents/ppr.pdfAccessed January 7, 2009.
  13. Messali A, Thomas O, Chauvin M, et al. Death due to an implantable cardioverter-defibrillator. J Cardiovasc Electrophysiol. 2004;15:953–956
  14. Vollmann D, Luthje L, Vonhof S, et al. Inappropriate therapy and fatal proarrhythmia by an implantable cardioverter-defibrillator. Heart Rhythm. 2005;2:307–309
  15. Kallinen LM, Hauser RG, Lee KW, et al. Failure of impedance monitoring to prevent adverse clinical events caused by fracture of a recalled high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm. 2008;5:775–779
  16. Swerdlow CD, Gunderson BD, Ousdigian KT, et al. Downloadable lead-integrity algorithm to reduce inappropriate shocks in patients with Sprint Fidelis leads. Circulation. 2008;118:2122–2129
  17. Kleeman T, Becker T, Doenges K, et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period >10 years. Circulation. 2007;115:2474–2480
  18. Hauser RG, Cannom D, Hayes DL, et al. Long-term structural failure of coaxial polyurethane implantable cardioverter defibrillator leads. Pacing Clin Electrophysiol. 2003;25:879–882
  19. Eckstein J, Koller MT, Zabel M, et al. Necessity for surgical revision of defibrillator leads implanted long-term (Causes and management). Circulation. 2008;117:2727–2733

 Dr. Hayes has received honoraria from Medtronic, Boston Scientific [Guidant], St. Jude Medical, Sorin/ELA, and Blackwell/Wiley; has served and/or is serving on an Advisory Board of Boston Scientific (Guidant), St. Jude Medical, Sorin/ELA, and AI-Semi; serves on a Steering Committee of St. Jude (DSMB); and has received royalties from Blackwell/Futura.

PII: S1547-5271(09)00175-1

doi: 10.1016/j.hrthm.2009.02.024

Heart Rhythm
Volume 6, Issue 5 , Pages 605-610 , May 2009

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