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Related Experiment Video

Updated: Mar 22, 2026

Experimental Procedure for Warm Spinning of Cast Aluminum Components
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Published on: February 1, 2017

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Small-Caliber Lead Failure After Generator Exchange.

Ricardo Salgado1, Javier Martín1, José Martínez2

  • 1University Hospital of Burgos, Spain.

Journal of Cardiovascular Electrophysiology
|April 20, 2016
PubMed
Summary

The Sprint Fidelis defibrillator lead does not show increased dysfunction after generator exchange (GE) compared to other leads. Preventive replacement is not recommended for normally functioning Fidelis leads before GE.

Keywords:
Sprint Fidelis leadgenerator exchangelead dysfunctionlead fracturesmall-caliber lead

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Area of Science:

  • Cardiology
  • Biomedical Engineering
  • Medical Device Technology

Background:

  • The Sprint Fidelis defibrillator lead was recalled in 2007 due to failure risks.
  • Generator exchange (GE) procedures have been linked to Fidelis lead dysfunction.

Purpose of the Study:

  • To compare the dysfunction rate of Sprint Fidelis leads versus other defibrillator leads in the first year post-GE.
  • To evaluate the necessity of preventive replacement for Sprint Fidelis leads before GE.

Main Methods:

  • A multicenter retrospective study using the UMBRELLA database.
  • Inclusion criteria: patients with normal lead function prior to GE and at least 1-year follow-up.
  • Lead dysfunction defined by impedance, sensing parameters, or noise on remote monitoring.

Main Results:

  • 531 patients included; 114 had Fidelis leads.
  • Overall lead dysfunction incidence within one year post-GE was 3.6%.
  • No significant difference in dysfunction rates between Fidelis (3.5%) and other leads (3.6%) (P=0.962).

Conclusions:

  • Preventive removal or replacement of normally functioning Sprint Fidelis leads before GE is not recommended.
  • The dysfunction rate of Sprint Fidelis leads after GE is comparable to other defibrillator leads.