It was reported, the patient had a seizure monday night post operation and again on the day of this report.The patient had swelling and edema near the site of the contacts by one of the implanted leads.The implantable neurostimulator (ins) had not been programmed or turned on after implant.Impedances were run during the operation.A ct scan was done and the cause of the event was unknown.The patient was still in the hospital and the device was not on.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.
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Product id 3387s-40, lot# va0hyjm, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0c4xs, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0hyjm, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va0c4xs, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6) ; product type extension product id 37642, serial# (b)(4); product type programmer, patient.(b)(4).
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