The refurbished pulse generator.
With the advent of long-life lithium pulse generators, normally functioning pulse generators with a potential life of more than five years have been removed from patients and become available for re-implantation. Although pulse generator refurbishing is widely employed, the practice has not been accepted in the United States. At The Royal Melbourne Hospital, all lithium pulse generators removed because of patient death or other causes were washed in a quaternary ammonium compound and soaked in formaldehyde. Pulse generators were than electronically tested and, if within specification, were made available for re-implantation. Pulse generators were then washed under sterile conditions in distilled water and gas-sterilized with ethylene oxide. Between 1975 and 1978 (48 months), 600 pulse generators were implanted and 93 pulse generators removed. There were 56 deaths, 22 cases of pre-erosion, erosion, or infection and 15 elective removals either due to lead problems or impending power source depletion. Eight-three (89%) pulse generators were refurbished (14% of total implants). This included 12 pulse generators refurbished on two occasions. Ten pulse generators were returned to manufacturers, seven because of impending power source depletion, two with suspected electronic faults, and one with a damaged case. Two complications occurred in patients with refurbished pulse generators. An infective process present with the previous pulse generator spread to a new pocket. The other pulse generator was removed 35 months post second implantation because of impending power source depletion. Primary infection or unusual tissue reactions did not occur. Pulse generator refurbishing as described was found to be a safe and economic procedure.
D011211:Electric Power Supplies; D005500:Follow-Up Studies; D006801:Humans; D008094:Lithium; D010138:Pacemaker, Artificial; D013242:Sterilization / Q000379:methods
D008094:Lithium