Delayed Pacemaker Erosion due to Electrode Seal Defects

Abstract

Over a 7-year period, follow-up data were available on 163 patients who underwent 209 pacemaker-related operations for initial insertion or revision of previously implanted units. During the follow-up period, 16 pacemaker generator units were removed from 12 patients solely because of the development of local skin erosion. This represents a 7.7% incidence of pacemaker generator erosion. Three units were removed within a 3-month interval following pacemaker implantation and were associated with positive bacterial cultures, thereby indicating an infectious cause. Findings at removal of the remaining 13 pacemaker generators included extensive fibrosis with chronic inflammation, fibroblastic proliferation, and granulation tissue, which was most prominent at the site of insertion of the pacemaker lead into the pacemaker generator unit. Granulation tissue frequently led from this area to the area of skin attenuation and erythema. Inspection of the pacemaker generator units and electrodes demonstrated fluid ingress and tissue ingrowth toward the electrode due to inadequate seal mechanisms. Inadequate seal design of the pacemaker generator and electrode junction leads to tissue ingrowth with fibroblastic proliferation, chronic inflammation, and eventual pacemaker erosion.