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

Model Number 1007603

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

Patient Problems Skin Erosion (2075); Numbness (2415)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device remains implanted.

Event Description

On (b)(6) 2015: the patient underwent implantation of the rns neurostimulator and four cortical strip leads.On 12/04/2015: product monitoring became aware of a neurostimulator reset.Follow up with the site identified that the patient had wound dehiscence and some drainage.The patient underwent a wound revision which included cleaning of the incision site and reclosure with electrocautery.Patient was placed put on antibiotics no evidence of infection from cultures obtained from incision site.The neurostimulator reset was cleared and is currently programmed for detection and therapy as prescribed.

Manufacturer Narrative

(b)(4).(b)(6) 2015 - initial implant procedure of the rns system with one cortical strip placed left lateral temporal, one placed right interhemispheric, one placed right posterior subtemporal and one placed right anterior subtemporal.(b)(6) 2015 - the patient reported wound dehiscence resulting in wound revision, this was reported to the fda, 3004426659-2015-00036.(b)(6) 2016 - neuropace became aware that the patient had a dc leak reset of their neurostimulator.The reset was mitigated as designed.Further investigation into the cause of the reset revealed that the patient had undergone a surgical procedure.Surgical details a second debridement was performed to address the wound dehiscence.The surgery was expanded to include lead removal.The patient had reported numbness on her face when she came in for a follow up.The neurosurgeon removed an unused sub temporal strip lead sn # (b)(4), on the off chance that it might be related to the numbness.Per the doctor "the patient had another procedure done on (b)(6) 2016 that was related to the wound revision and that the patient had numbness feeling in her face and they removed one of the unused strips (sub temporal) just in case this was causing it." the patient rns system is currently programmed for detection and treatment.The strip was discarded by the site.Feb.04, 2016 additional information forwarded by the fce - after surgery, for the time of her stay, she (the patient) wasn't sure that the numbness had improved (b)(4).Serial number (b)(4) was explanted.Patient was administered vancomycin via picc.Device remains implanted.

Event Description

New information regarding patient condition was received.

• 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: 5322736
• MDR Text Key: 34242906
• Report Number: 3004426659-2015-00036
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017151211
• 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: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007603
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2015
• 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; Required Intervention
• Patient Age: 27 YR