Pacemaker‐Related Patient Mortality

Little is known about the incidence of technical defects and malfunctions of pacemaker pulse generators. During 1986 only 2 articles of 13 in PACE gave concrete failure numbers: between 1.2% and 3.4% per year. Our estimation of technical failure rates gained by evaluating the data of the German Pacemaker Registry varied between 2 × 10 −3 annually in 1992 and 0.7 × 10 −3 annually in 1997. This data was derived from clinical information about pulse generator replacements required due to a technical defect. Are the numbers derived from replacement procedures a complete picture of the failure incidence? Two additional sources were evaluated to answer this question: the “death related file closure” data of the German Pacemaker Registry and the testing of 3,050 pacemakers removed from deceased patients. The results seem to indicate that there may be three times as many generator defects as calculated from replacement data. About one‐third of the defective generators were found in deceased patients, which led to the question of how this can be explained. Roughly another third was reported by the physicians to be the cause of the patient's death. If one hypothesizes that the same situation and ratios will exist for other critical situations such as sensing or lead defects, a total annual defect or malfunction incidence of 3.8 × 10 −3 can be projected. The majority of malfunctions remains undetected during the lifetime of the pacemaker patients. The minority only can be detected if the patients survive situations. As the mean lifetime of a pacemaker patient is 6 years after implant, at least in Germany, 1 of 62 patients died in the past with or, alternatively, because of a recognized or unrecognized malfunction of the pacemaker system.