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

Model Number DL-330-10-K

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Lead revision, insufficient charge.Depth lead s/n (b)(4) (port 2, right parietal inferior secured with burr hole cover) demonstrated insufficient charge on 2 electrodes and showed a flat signal.Troubleshooting included replacing the connector cover, multiple impedance measurements, and switching the lead between ports confirming that there was a lead issue.The lead was replaced on (b)(6) 2017.

Manufacturer Narrative

(b)(4).The patient was initially implanted with rns neurostimulator and four depth leads.All depth leads were secured with a burr hole.Investigation results: evaluation of ecog data is indicative of a suspected lead break (on port2).Investigation of the returned lead, confirmed the lead body and coil were damaged near the location of the burr hole cover.A new depth lead was implanted and connected to port2.The patient is currently programmed for detection and therapy by the rns system.

• 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: 6646430
• MDR Text Key: 77773648
• Report Number: 3004426659-2017-00026
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005041
• UDI-Public: 0100855547005041718121021192905
• 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,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 21520-1-1-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• 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; Other
• Patient Age: 18 YR