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

Model Number DL-344-10-K

Device Problems Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2017

Event Type  malfunction  

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 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
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 6502382788
• MDR Report Key: 6868528
• MDR Text Key: 86413082
• Report Number: 3004426659-2017-00042
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417100120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR