It was later reported the patient underwent a successful full revision.The pre-op interrogation of the patient's device showed low impedance.When explanting the m103 generator, the surgeon stated there was an obvious lead fracture near the generator, but he was not able to determine the cause of the fracture.The m103 generator and the old lead, up to the point of the anchor tether, were explanted and the electrodes were left in place.A new lead and generator were implanted with the new electrodes placed superior to the old electrodes.System diagnostics were checked for the newly implanted vns and noted to be within normal limits.The explanted product was sent to pathology per hospital protocol.The explanting facility does not return devices back to the manufacturer; therefore, the devices are not expected to be returned for analysis.
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