The care of patients at increased risk of premature pacemaker failure.

During 1975 to 1977, a series of advisory notices from a pacemaker manufacturer alerted us to an increased probability of sudden, premature pacemaker failure in 217 patients. Three possible responses to these recalls were used among these patients: prophylactic pulse generator change, increased surveillance without pulse generator change, and routine surveillance with replacement only after pacing failure. During the three years after implantation of these pulse generators, 30 sudden failures and 19 incidents of rate decrease indicating impending failure were observed; all were corrected by pulse generator replacement. Among the 50 deaths were six for whom terminal pacemaker status information was inadequate, but overall mortality was not notably different from other pacing series. Consideration of recalls should include projected frequency of failure, expected mode of failure, patient dependence on pacing, and presence of coexisting diseases.