Corrosion and degradation of a polyurethane/Co-Ni-Cr-Mo pacemaker lead.
An investigation to study changes in the metal surfaces and the polyurethane insulation of heart pacemaker leads under controlled in vitro conditions was conducted. A polyurethane (Pellethane 2363-80A)/Co-Ni-Cr-Mo (MP35N) wire lead was exposed in Hanks' physiological saline solution for 14 months and then analyzed using scanning electron microscopy, x-ray energy dispersive analysis, and small angle x-ray scattering. Results showed that some leakage of solution into the lead had occurred and changes were present on both the metal and the polyurethane surfaces.
Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20857.
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D000497:Alloys; D003343:Corrosion; D008855:Microscopy, Electron, Scanning; D010138:Pacemaker, Artificial; D010539:Permeability; D011140:Polyurethanes; D012542:Scattering, Radiation
D000497:Alloys; D011140:Polyurethanes