Lead fracture, occurring in approximately 1%-4% of patients, is an infrequent, but potentially catastrophic complication of permanent pacing systems. Its incidence in transvenous defibrillator systems has not been established. We analyzed data from 757 patients undergoing implantation of transvenous cardioverter defibrillator systems using the Medtronic Transvene Lead system between October 20, 1989 and June 25, 1992 to determine if site of venous approach influenced incidence of lead fracture. All patients received a 3-lead system in 1 of 3 configurations: (1) right ventricle/superior vena cava/subcutaneous patch; (2) right ventricle/coronary sinus/subcutaneous patch; or (3) right ventricle/superior vena cava/coronary sinus. Of 767 right ventricular leads placed, 523 were placed via the subclavian vein, 221 via cephalic vein, and 18 via the internal jugular (5 leads were implanted using another vein). The total number of leads is greater than the total number of patients, as five patients received a second defibrillator system if the initial system was explanted and reimplanted for any reason. Seven patients (0.9%) had right ventricular lead fracture, presenting with inappropriate defibrillator shocks (1), loss of pacing ability (3), both loss of pacing ability and inappropriate shocks (1), or increased pacing threshold (2). All patients required reoperation. All had leads placed by the subclavian venous approach, with chest X ray confirming fracture at the clavicle-first rib junction in 6 of 7 cases. Using Fisher's Exact test, the difference in lead fracture between subclavian and cephalic vein implant approached statistical significance (P = 0.08). The trend toward increased lead fracture incidence with leads placed via subclavian vein suggests that cephalic vein approach may be preferable to avoid this complication.