It was reported that the patient's mother had noticed some redness and swelling at the implant site.The patient's generator and lead were removed shortly after due to wound infection at the generator and neck sites.A review of device history records showed that the implanted generator and lead were sterilized prior to distribution.All other quality tests also passed prior to distribution.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No other relevant information has been received to date.
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