On (b)(6) 2014: initial implant of rns neurostimulator (rns-300m-k) and (3) neuropace cortical strip leads (cl-325-10-k) placed over left occipital region, left supra-sylvian and left posterior superior.Along with (1) neuropace depth lead (dl-330-10-k) placed in the left insula.The rns system implant followed a phase ii invasive monitoring that was 7 days in duration.Intracranial electrodes (non neuropace electrodes) were removed and the rns system was implanted.On (b)(6) 2014: neurosurgeon brought patient to or to remove rns-300m-k, ferrule, (3) x cl-325-10-k and (1) dl-330-10-k for suspected wound infection.On (b)(6) 2014: communication with the neurosurgeon, werner doyle, md indicated that the patient has a wound infection that he described as a "subdural infection (empyema) and cerebritis." neurosurgeon stated that the "infection appears under control and his symptoms are resolving." on (b)(6) 2014, per the field clinical engineer, the culture was identified as an enterobacter.
|