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

Model Number RNS-300M-K - FGI, NS, RNS-300M-K

Device Problem Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Remains implanted.

Event Description

The rns reset to inactive mode when the battery reached end of life after being implanted for approximately 1.4 years.Ram code reinstallation was scheduled for (b)(6) 2016, the patient missed his appointment.The device is currently inactive.The patient has not rescheduled.He and his physicians know that the device is at end of life.

Manufacturer Narrative

(b)(4).On 10/19/2016 ram code was reinstalled in the neurostimulator device.The eos reset was cleared and the battery measurement was 2.73v, review of device sessions did not confirm device failure.On 11/3/2016 the rns reached eos and the device reset to inactive mode.On 1/4/2017 investigation completion: software and electrical engineering reviewed the device diagnostics.The analysis showed that the neurostimulator spent several programming epochs delivering high therapy loads so that a shortened battery life would be expected.Due to the partial nature of the available data it was not possible to determine exactly how much shorter than typical the battery life would be.A review of the battery discharge over time indicated a normal battery discharge.This analysis did not preclude the possibility that the device depleted prematurely.The device is currently inactive and remains implanted in the inactive mode.

• 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: 5983372
• MDR Text Key: 55815741
• Report Number: 3004426659-2016-00025
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017150909
• 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
• Reporter Occupation: Device Unattended
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: RNS-300M-K - FGI, NS, RNS-300M-K
• Device Catalogue Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• 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): Other
• Patient Age: 29 YR