PMID: 8945048Nov 1, 1996Paper

Failure rates of leads, pulse generators, and programmers have not diminished over the last 20 years: formal monitoring of performance is still needed. BILITCH Registry and STIMAREC

Pacing and Clinical Electrophysiology : PACE
D T KawanishiJ F Godin

Abstract

Formal Monitoring of Performance is Still Needed. In order to detect trends in the number of device or component failures that have occurred among permanent pacemaker systems since the 1970s, we reviewed the data of the five largest pacemaker manufacturers from the Bilitch Registry of permanent pacemaker pulse generators, the Stimarec failure registry, the general accounting office summaries of the United States Veterans Administration (VA) Registry of Pacemaker Leads, and the Implantable Lead Registry, from the Cleveland Clinic Lead registry, and the recalls and safety alerts issued by the United States Food and Drug Administration (FDA) over the last 20 years. The definition of failure followed the criterion, or criteria, developed within each registry and differed significantly between the registries. The 20-year period between 1976 and 1995 was divided into 5-year quartiles (QT): QT 1 = 1976-1980; QT2 = 1981-1985; QT3 = 1986-1990; and QT4 = 1991-1995. For pulse generators, the number of models with failures in each quartile in the Bilitch Registry were: QT 1 = 9; QT 2 = 11; QT3 = 17; QT4 = 13. In Stimarec, the number of units reported as having reached a dangerous condition were: QT1 = 710; QT2 = 212; QT3 = 114; QT4 = 310. ...Continue Reading

References

Jul 1, 1992·Pacing and Clinical Electrophysiology : PACE·D L HayesM Seebandt
Dec 1, 1990·Pacing and Clinical Electrophysiology : PACE·S Furman, Z M Benedek
Jan 1, 1994·Pacing and Clinical Electrophysiology : PACE·M E HelgueraL W Castle
Apr 1, 1994·Pacing and Clinical Electrophysiology : PACE·S Furman
Apr 1, 1994·Pacing and Clinical Electrophysiology : PACE·S L Song
Apr 1, 1995·Pacing and Clinical Electrophysiology : PACE·J F GodinG Pioger
May 1, 1995·Pacing and Clinical Electrophysiology : PACE·J A Brinker

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Citations

Jul 18, 2006·The Heart Surgery Forum·Tatiana FleckMartin Grabenwoger
Sep 15, 2004·Journal of Cardiovascular Electrophysiology·R Andrew PickettJeffrey N Rottman
Jul 5, 2005·Heart Rhythm : the Official Journal of the Heart Rhythm Society·N A Mark Estes
Apr 11, 2003·Pacing and Clinical Electrophysiology : PACE·Patrick T EllinorBrian A McGovern
Feb 25, 1998·Pacing and Clinical Electrophysiology : PACE·T FahraeusD Cooke
Jul 29, 2000·Pacing and Clinical Electrophysiology : PACE·T R PrattM S Stanton
Dec 17, 2003·Pacing and Clinical Electrophysiology : PACE·Osnat GurevitzMichael Glikson
Jun 3, 1999·Pacing and Clinical Electrophysiology : PACE·M S KiviniemiJ E Hartikainen
Apr 26, 2006·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Angelo AuricchioUNKNOWN Writing Committee for the European Heart Rhythm Association Guidance Document on Cardiac Rhythm Management Product Performan
Mar 16, 2017·Pacing and Clinical Electrophysiology : PACE·Melissa E MiddeldorpPrashanthan Sanders
Jun 2, 2000·Pacing and Clinical Electrophysiology : PACE·M H Schoenfeld, H T Markowitz
Oct 20, 1999·Pacing and Clinical Electrophysiology : PACE·W Irnich
Apr 14, 2004·Pacing and Clinical Electrophysiology : PACE·David NewmanBernard Goldman

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