It was reported that a vns patient was scheduled for generator replacement due to battery depletion.The communication was reported to be okay prior to generator replacement, but after the generator replacement high impedance was found.The surgeon found a broken electrode.A new electrode was installed, and the patient was in good condition with impedance measurements within normal limits of 1,416, 1,562, and 1,445 ohms.The explanted devices were received and analysis is underway, but has not been completed to-date.Additional relevant information has not been received to-date.
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Analysis was completed for the returned lead.The electrode array portion was not returned and evaluation could be made on that portion of the lead.The lead was found to have been cut, and two pieces were returned.Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portions.
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