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Model Number RNS-300M |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Seizures (2063)
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Event Date 07/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial implant included rns neurostimulator and two cortical strip leads.Port 1 cl-325-10, sn (b)(4), left temporal, anterior.Port 2 , cl-325-10, sn (b)(4), left temporal posterior lead.
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Event Description
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Neuropace was notified on july 9, 2017 that the patient was admitted for what appeared to be an ischemic stroke after presenting with a flurry of seizures on (b)(6).Clinically the patient reported a headache but no other symptoms were noted.As a precautionary measure, the site decided to disable therapy on the rns system on (b)(6), however detection remained enabled.After further evaluation, the center reported that the event did not appear to be an ischemic event but would continue to evaluate.As of (b)(6), the patient was reported to be stable and not exhibiting any stroke-like clinical symptoms.Imaging was reported to be more consistent with vasogenic edema than an ischemic stroke.Since the patient remained stable, no invasive interventions (e.G.Biopsy or explant of rns system product) were planned.At the time of report, the patient remained hospitalized for monitoring.
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Search Alerts/Recalls
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