Damage to the insulation was found in leads covered with polyurethane resin. The surface of the leads with damaged insulation responded positively to fluorecent staining. Under a scanning electron microscope, the surface of the internal wall appeared smooth, but cracks were seen on the surface of the external wall. The damaged leads were sliced perpendicular to their longitudinal axis and photoelasticity tests disclosed patterns on the surface wall, suggesting the presence of residual stress. This resin can be extruded or cast to form a pipe which is then made into a lead by inserting metal wires into the lumen. These leads were probably exposed to compressive stress on their internal wall surface and residual stress (tensile stress) on the external wall surface. Such stresses were what were probably detected by photoelasticity tests. We speculate that the tension of external forces (bending, pulling, surface ligating, etc.) after implantation, combined with the residual stress, exceeded the durable stress limitation of polyurethane resin, resulting in cracking. This phenomenon was not seen in silicon resin leads, suggesting that leads made of polyurethane resin are subject to problems not only in the manufacturing process but also in the nature of the material itself. These results indicate that attention should be paid to the external forces mentioned above when polyurethane resin leads are used, and also to the course of patients after implantation of pacemakers with such leads.
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