FAILURE RATES OF LEADS, PULSE GENERATORS, AND PROGRAMMERS HAVE NOT DIMINISHED OVER THE LAST 20 YEARS - FORMAL MONITORING OF PERFORMANCE IS STILL NEEDED

Formal Monitoring of Performance is Still Needed. In order to detect t rends in the number of device or component failures that have occurred among permanent pacemaker systems since the 1970s, we reviewed the da ta of the five largest pacemaker manufacturers from the Bilitch Regist ry of permanent pacemaker pulse generators, the Stimarec failure regis try, the general accounting office summaries of the United States Vete rans Administration (VA) Registry of Pacemaker Leads, and the Implanta ble Lead Registry, from the Cleveland Clinic Lead registry, and the re calls and safety alerts issued by the United States Food and Drug Admi nistration (FDA) over the last 20 years. The definition of failure fol lowed the criterion, or criteria, developed within each registry and d iffered significantly between the registries. The 20-year period betwe en 1976 and 1995 was divided into 5-year quartiles (QT): QT1 = 1976-19 80; QT2 = 1981-1985; QT3 = 1986-1990; and QT4 = 1992-1995. For pulse g enerators, the number of models with failures in each quartile in the Bilitch Registry were: QT1 = 9; QT2 = 11; QT3 = 17; QT4 = 13. In Stima rec, the number of units reported as having reached a dangerous condit ion were: QT1 = 710; QT2 = 212; QT3 = 114; QT4 = 310. From the FDA rep orts, the number of units included in recalls or safety alerts were: Q T3 = 6,085; QT4 = 135,766. For permanent pacemaker leads, the numbers of failed or dangerous leads recorded in Stimarec were: QT3 = 16; QT4 = 32. In the VA Registry, the number of models having a below average survival was 2/92 (2.7%). In the Implantable Lead Registry,;the number of models having a below average survival was 3/21 (14%). In the Clev eland Clinic series, 6/13 (46%) of lead models were recognized to have some failure involving the conductor, insulation, or connector. In th e FDA reports, the number of leads involved in either recall or safety alert were: QT3 = 20,354; QT4 = 332, 105. For programmers, the number of units involved either in a recall or safety alert were: QT3 = 11,1 24; QT4 = 3,528. In all of these series, each of the five largest manu facturers had some models or units involved in each time period. This review of programs has revealed: 1. The incidence of failures, recalls , or safety alerts did not decline over time; and 2. Despite changes i n technology, formal monitoring of pacemaker systems is still warrante d.