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

Model Number RNS-320-K

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the explanted product was not returned to neuropace for analysis.

Event Description

The patient underwent initial placement of the rns system on (b)(6) 2019.Approximately 4 months after initial placement, the rns neurostimulator had reached eos voltage, indicating a potentially prematurely depleted device.The patient underwent a neurostimulator replacement procedure on (b)(6) 2019.The explanted device has not yet been returned to neuropace for analysis.

Manufacturer Narrative

Comp-(b)(4).The explanted product was returned to neuropace for analysis.Upon receipt of the explanted device, neuropace confirmed that the device was at eos and was not communicating with the rns system tablet.The manufacturing history of this device was reviewed and nothing abnormal was found.The rns neurostimulator performed as expected during the manufacturing process.Review of the battery measurement plot in the pdms identified a battery voltage drop.The plot indicated that the battery voltage was stable before a programming change was made on 09/03/2019 and indicates that it was the programming that triggered a high current state.Investigation of the device was performed.The source of the battery depletion was attributed to a sub-circuit component exhibiting a latent defect.It was the result of the defective component not operating correctly during programming, which resulted in the device drawing high current.The source of the defect to the component cannot be identified.

Event Description

The explanted device was returned to neuropace and investigated.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca CA 94043
• MDR Report Key: 9501355
• MDR Text Key: 211497915
• Report Number: 3004426659-2019-00054
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200305
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 2760-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR