It was reported that the patient's generator and leads were explanted due to an infection.The patient reportedly picked at their generator and electrode incisions following their implant surgery.The physician assessed that the infection was not related to the vns implant surgery but was related to the patient falling on something which led to the device extruding.The extrusion and the subsequent infection were reportedly related to the patient's fall.A review of device history records for the generator and the lead shows that both were sterilized prior to release for distribution.All other quality inspections were completed and passed.Device evaluation is not necessary as reported events are not related to the functionality or delivery of therapy of the device.No further relevant information has been received to date.
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