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

Model Number	DL-344-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Note the patient is currently implanted with the rns system: rns neurostimulator (b)(4) and two depth leads (port 1 dl-330, (b)(4) and port 2 dl-344 (b)(4).
Event or Problem Description
During a review of the patient's neurostimulator data on (b)(6) 2016, neuropace personnel noted that there was a change in signals noted on the patient's right depth lead indicative of a fracture.The treating physician was notified of this prior to the patient's appointment.During the patient appointment, another impedance measurement was taken which demonstrated "insufficient charge" on 3 of the 4 electrodes.Therefore, the physician elected to disable detection and stimulation on that lead and monitor the patient's response.As of a year later, the patient reported no seizures and was doing well.As of (b)(6) 2017, the neuropace field clinical engineer was informed that the lead had been explanted on (b)(6) 2016.The explanted product was returned to neuropace for investigation.It was reported that the neurosurgeon used a dog bone to secure the depth lead and then used a weck hemolock to mark the location where the lead entered the brain.The investigation was inconclusive.Only a partial lead was returned; the distal end of the lead was missing.The lead appeared to be damaged significantly during the explant process which impeded identification of the cause of the lead break.The patient remains implanted with the rns system neurostimulator and two depth leads with both detection and stimulation currently enabled.

• 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: 6868528
• Report Number: 3004426659-2017-00042
• Device Sequence Number: 890546
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417100120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/15/2017

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: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 19670-1-1-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/15/2017
• 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: 28 YR