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Estella Pulse Generators - BIOTRONIK USA - News

Estella Pulse Generators - BIOTRONIK USA - News

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14. Explantation<strong>Estella</strong> <strong>Pulse</strong> <strong>Generators</strong> Technical Manual 121Explanted pulse generators or explanted accessories may not be reused.Explanted pulse generators can be sent either to the local <strong>BIOTRONIK</strong>representative or the <strong>BIOTRONIK</strong> home office for expert disposal.If possible, the explanted pulse generator should be cleaned with asodium‐hyperchlorine solution of at least 1% chlorine and, thereafter,washed with water prior to shipping.The pulse generator should be explanted before the cremation of adeceased patient.CautionDevice Incineration—Never incinerate a pulse generator. Besure the pulse generator is explanted before a patient who hasdied is cremated.Explanted Devices—Return all explanted devices to <strong>BIOTRONIK</strong>.14.1 Common Reasons to Explant a <strong>Pulse</strong> GeneratorA pulse generator may be explanted emergently or at a physician’sdiscretion at any time subsequent to an implant procedure. Reasonsfor explant include, but are not limited to: patient death; no output/intermittent output; loss of capture/ sensing; inability to program/interrogate the pulse generator; infection, EOS (normal or premature);system upgrade; physician preference for another pulse generatormodel; and/or other reason(s) which may or may not be known to thepulse generator manufacturer. Complications related to other portionsof the pacing system (i.e., lead, patient) may also result in pulsegenerator explant. Table 34 summarizes some of the more commonreasons for pulse generator explant.

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