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

Model Number RNS-300M - KIT,

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6), implant details the patient has four implanted leads - port 1 strip is right frontal inferior anterior, port 2 depth is right frontal insula, strip not connected right frontal superior anterior, strip not connected right temporal superior temporal gyrus.Dr.(b)(6) is the following physician.Product remains implanted.

Event Description

Dr.(b)(6) at (b)(6) reported his neuropace rns system patient, (b)(6) implanted in (b)(6) 2015, was brought into (b)(6) last night as he suffered a hemorrhage in his right frontal lobe.Dr.(b)(6) did not think that the event was device related but did solicit advice on how to proceed with an rns system implanted patient with a hemorrhage.The patient is being observed right now and no further intervention has been planned as of this morning.After conferring with dr.(b)(6), the rns system will be left enabled until further notice.The patient is stable and will be discharged soon.The event is believed to be spontaneous and venous in nature.No further intervention is planned at this time.Aside from a minor facial droop, (b)(6) is alert and doing well.

• 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: 6281878
• MDR Text Key: 65897097
• Report Number: 3004426659-2017-00001
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017150728
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS-300M - KIT,
• Device Catalogue Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 31 YR