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

Model Number RNS NEUROSTIMULATOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erosion (1750); Fluid Discharge (2686)

Event Date 07/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device remains implanted.

Event Description

On (b)(6) 2015 patient was implanted with the rns neurostimulator and two depth leads (dl-330-10-k and dl-344-10-k) on 07/30/2015 the fce was notified that the patient had some drainage from their neurostimulator incision line.The subject was placed on antibiotics.On (b)(6) 2015 the patient underwent surgery.Surgery included flushing and cleaning of the site.The rns system was not explanted.The physician interrogated after the procedure and verified there was no dc leak.The rns system is programmed for detection and therapy.

Manufacturer Narrative

(b)(4).Feb.01, 2016: neuropace representative spoke to (b)(6) at (b)(6) regarding patient (b)(6) on (b)(6) 2016.The event reported in (b)(6) 2015, is ongoing.The patient was examined on (b)(6) 2016 and it was determined that a procedure will be performed on (b)(6) 2016 to remove the left depth lead due to exposure at the burr hole entry location.Part no.1007607, dl-344-10-k, serial number (b)(4).Lead not returned.

Event Description

Feb.01, 2016 new information regarding patient status.

Manufacturer Narrative

(b)(4).Patient was implanted on (b)(6) 2015 with neuropace rns neurostimulator and (1) dl 44cm/10mm and (1) dl 30cm/10mm.Mfr report 3004426659-2015-00024 - on (b)(6) 2015 a debridement procedure was performed patient was noted in clinic to be constantly picking at her incision locations.In early (b)(6) 2016 the left burr hole location became exposed secondary to the patient continuing to pick at her incisions.The neurosurgeon elected to explant the left depth lead sn: (b)(4) and in order to remove the lead needed to expose the neurostimulator incision as well.The patient continued to pick at her incisions which again created exposure of the neurostimulator.The neurosurgeon elected to explant all product on (b)(6) 2016.Device not returned.

• 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: 5024978
• MDR Text Key: 23850961
• Report Number: 3004426659-2015-00024
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 01008555470051201715120300010121190704
• 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: Followup,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Device Catalogue Number: RNS-300M-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• 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; Required Intervention
• Patient Age: 38 YR