MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number	1007607
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The patient is currently implanted with the rns system which is programmed for detection.Device history and sterilization review was 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.Device history records for product assembly met requirements and passed quality control inspections.The depth lead and stylet were returned and investigated.Investigation identified that the style failed near where it is joined to the stylet retainer.The stylet failed due to a bending load.Neuropace is unable to identify the root cause of this failure.
Event or Problem Description
During an rns system implant procedure and after the surgeon placed the depth lead, the surgeon went to remove the stylet from the depth lead and it sheared off right at the plastic clasp.The remainder of the stylet could not be removed from the depth lead and the surgeon had to explant the implanted depth lead.A replacement lead was implanted and the patient is currently implanted with the rns system programmed for detection.Additional follow up: the surgeon was set up for depth lead insertion when the stylet broke so there was no significant delay to reinsert the new lead (the fce estimated 10 minutes).The fce reported the patient was not affected.The lead was removed and a new depth lead was inserted during surgery.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 5438324
• Report Number: 3004426659-2016-00001
• Device Sequence Number: 13535855
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 01008555470050141718021100010121190790
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 1007607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2016
• Initial Report FDA Received Date: 02/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR