The Impact of a Manufacturer's Revision of Pacemaker Service Life on the Workload of a Large Pacing Center

Abstract

In certain batches of a manufacturer's pacemakers, inadequate insulation of the battery cell feed-through mechanism led to internal short-circuiting and premature battery depletion. We describe the impact of the consequent reduction in service life and recommended close supervision of these generators on the follow-up clinics and inpatient workload at a large pacing center. One-hundred and ninety patients had Cordis Gamma series pacemakers implanted between September 1981 and July 1985; 135 have had to undergo premature generator replacement. Eleven of these pacemakers had developed early depletion of rate and 12 no-output failure. Within 3 months of their generator change, 12 patients developed wound sepsis, three of them requiring further system replacement. We calculate that at least 540 extra outpatient appointments, 400 in-hospital patient days and 12 full working days in one of our catheterization laboratories were required to deal with the problems. The pacemaker industry, as well as doctors and technicians involved in pacemaker purchase and implantation, should be aware of the consequences of a major recall not only on workload but also on patient morbidity and anxiety.