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Model Number RNS NEUROSTIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/12/2013 |
Event Type
Injury
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Event Description
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On (b)(6) 2013 - the patient had her third neurostimulator replacement procedure.The rns system configuration for this subject includes a rns neurostimulator, one cortical strip lead (connected, cl-315-10) a depth lead (connected, dl-330-10) and a depth lead (dl-344-10, not connected).Prior to the replacement intraoperative cultures were taken and were positive for gram positive bacillus on gram stain.At time of surgery there were no overt signs of infection.Patient denies fevers, chills or sweats prior to surgery.Patient had no complaints of pain and noted no drainage from the incision site.Blood work obtained revealed a normal white blood count.The neurostimulator replacement procedure occurred (b)(6) 2013.
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Manufacturer Narrative
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(b)(4).On 5/12/2015 during the adverse event review for the pas study it was identified that this event had not been reviewed according to the complaint handling process.Once identified this record was generated to meet the complaint review process.Neuropace, inc.Voided this complaint.There was no reported product malfunction and no indication the product contributed to the infection.Infections are anticipated when performing craniotomy procedures.On 7/17/2015 neuropace, inc.Reevaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with incision site infections are reportable.These past events show no indication that the product caused the infection and there is no indication of product failure.Sterility record review performed.No evidence of factors that could have caused or contributed to the reported event.All sterilization results met requirements as specified in the specifications.The patient is currently implanted with the rns system and is programmed for detection and therapy.Product remains implanted.
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Search Alerts/Recalls
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