(b)(6) 2014 - the subject was implanted with the rns neurostimulator and (4) cortical leads.Connected to the device, cl-325-10-k and cl-315-10-k.Not connected to the device but also implanted, cl-325-10-k and cl-325-10-k (b)(6) 2014 - the subject's husband reported that the incision was open at the site of the implant.The subject returned to have the incision reclosed.(b)(6) 2014 - the subject returned to the neurologist for follow-up.The surgeon was happy with how the incision was closing.(b)(6) 2015 the rns system remains implanted and is programmed for detection and therapy for epilepsy treatment.
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(b)(4).5/07/2015 neuropace, inc.Voided this complaint.There was no reported product malfunction and no indication the product contributed to the event.The risk of the noted condition had been previously assessed and mitigated, and the routine actions taken were consistent with standard patient care, providing effective treatment for the subject.7/7/2015 neuropace, inc.Reevaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with wound healing may be reportable.These past events show no indication that the product caused the wound not to heal and there is no indication of product failure.The rns system remains implanted and is programmed for detection and therapy for epilepsy treatment.Device remains implanted.
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