• Heart Rhythm · Aug 2012

    Comparative Study

    Class I recall of defibrillator leads: a comparison of the Sprint Fidelis and Riata families.

    • Jeffrey Liu, Genevieve Brumberg, Rohit Rattan, Sandeep Jain, and Samir Saba.
    • Cardiac Electrophysiology Section, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, USA.
    • Heart Rhythm. 2012 Aug 1; 9 (8): 1251-5.

    BackgroundIn recent years, 2 popular implantable cardioverter-defibrillator (ICD) leads have undergone a class I recall by the Food and Drug Administration (FDA): the Sprint Fidelis and the Riata leads.ObjectiveTo examine the failure rates of these 2 leads with respect to their date of FDA recall.MethodsAll patients implanted with a Sprint Fidelis, Riata, or Sprint Quattro lead at our institution were included. Kaplan-Meier failure-free survival curves were constructed with and without censoring at the dates of announcement of the FDA recall for each lead.ResultsA total of 2270 patients (623 Sprint Fidelis, 627 Riata, and 1020 Sprint Quattro) were included. The failure-free survival of the Sprint Quattro lead was significantly better than that of the Riata lead (P <.0001), which in turn was better than that of the Sprint Fidelis lead (P = .0214). After censoring events at the time of the FDA recall for each lead, the failure-free survival of the Sprint Quattro lead continued to be superior to that of the Riata (P <.0001) and Sprint Fidelis (P = .0124) leads but the difference between the Riata and Sprint Fidelis leads was eliminated (P = .123).ConclusionsIn this study, a comparative analysis of the failure-free survival of 2 recalled leads demonstrates discrepancies in the timing of the recall despite comparable failure-free survival patterns leading to the recall. The causes of these discrepancies are unclear and raise questions regarding the consistency of postmarketing surveillance and manufacturers' reporting of malfunctions of medical devices.Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…

What will the 'Medical Journal of You' look like?

Start your free 21 day trial now.

We guarantee your privacy. Your email address will not be shared.