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

Model Number RNS-300M-K

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

Patient Problems Injury (2348); No Code Available (3191)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2017 - pt implanted with rns system including the generator (located right parietal region), depth lead (sn (b)(4), port 1, right frontal), cortical lead, (sn (b)(4), port 2, right frontal).The system was only programmed for detection when the patient fell.Initial implant took 2 hours, pt had no invasive monitoring and no vns, burr hole cover was used incision was closed with sutures and staples, no vancomycin powder was used.The returned rns system was investigated.There was no indication of product failure or factors that could have contributed to the event.Product not received.

Event Description

On (b)(6) 2017 the patient fell during a seizure and hit his head causing the incision to open wide enough to visibly see the device.The patient was immediately taken to the vanderbilt er.Due to contamination concerns, dr.(b)(6) elected to schedule the patient for explanation on (b)(6) 2017 and requested the fce come to interrogate the neurostimulator to collect any data, prior to the removal.Upon interrogation, it was determined that the neurostimulator had been reset.The reset was cleared, detection was disabled, impedance measurements were taken and then the data was synchronized up to pdms.Dr.(b)(6) successfully removed the neurostimulator, ferrule tray, depth and cortical strip leads without complication.She covered the craniotomy with mesh.The rns system will be returned to neurospace.At the time of the event the rns system was programmed for detection only, therapy had not been activated.

• 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: 6391477
• MDR Text Key: 69488507
• Report Number: 3004426659-2017-00011
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170530
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2017
• 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: 21 YR