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

Model Number RNS-320-K

Device Problem Failure to Interrogate (1332)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted device was returned and investigated.The implanted neurostimulator began experiencing errors shortly after stimulation was enabled.The investigation identified the issue as a corrupted measurement diagnostic which was interpreted by the software as an invalid value, resulting in no data uploaded to pdms after interrogation.The failure was confirmed to be a defect in a specific integrated circuit (asic) involved in the temporary storage of data prior to transmission (referred to as a storage buffer).The failure was not detected during manufacturing testing.Neuropace performs testing of the buffers with standard telemetry commands and random data, but testing is not able to cover every possible pattern.Neuropace is currently assessing the manufacturing process and vector test coverage.

Event Description

The patient underwent initial placement of the rns system on (b)(6) 2021.On 5/3/2021, the treating center reported to neuropace that the patient had successfully interrogated their neurostimulator with the remote monitor and had uploaded the data to pdms (received a "successful transmission" message via the remote monitor).However no data was present in pdms.The patient was seen in the clinic on (b)(6) 2021 for troubleshooting and device programming (including re-installation of the neurostimulator firmware).The patient again attempted to interrogate on (b)(6) 2021, received the same message via the remote monitor, and again no data was seen on pdms.On (b)(6) 2021 the rns neurostimulator was replaced without complication.

• 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: 12174188
• MDR Text Key: 264766529
• Report Number: 3004426659-2021-00036
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617211124
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1007927
• Device Lot Number: 30847-1-1-1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/15/2021
• 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: 28 YR