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

Model Number RNS-320-K

Device Problem Failure to Interrogate (1332)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Exhibited a reset after implant subsequent to detection being enabled for the first time.The root cause of this failure has been traced to a random manufacturing defect in the logic circuit.

Event Description

The rns neurostimulator was placed without complications on (b)(6) 2019.However while attempting to interrogate the device in the recovery room the device displayed an alert message preventing further programming.A firmware update was applied to the device, which allowed the device to be interrogated and programmed.However the alert message reoccurred.A review of the device data determined that the rns neurostimulator underwent an unrecoverable error and would need to be replaced.The patient was in stable condition throughout the troubleshooting.The patient underwent a device replacement procedure without complications on (b)(6) 2019.

• 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: 8498194
• MDR Text Key: 141492588
• Report Number: 3004426659-2019-00009
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717191121
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 27147-1-1-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 17 YR