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.
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Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20857.
Fraker
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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