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

Model Number RNS 320

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problem Fall (1848)

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results - investigation in process.Neuropace confirmed a significant dent on the explanted neurostimulator can.

Event Description

The patient reported that he was unable to interrogate his device after experiencing a fall.The neurostimulator was replaced on (b)(6) 2023.A significant dent was noted on the top can of the neurostimulator when it was explanted.The neurostimulator was returned for investigation.

Manufacturer Narrative

(b)(4).Investigation results: testing confirmed an intermittent connection in the pca circuit.This pca was subjected to a severe impact transmitted from the device can through the internal frame.Most probably the impact to the pca cracked some number of solder ball connections between the sdbga and the pca or possibly traces in the pcb itself were compromised.The intermittent electrical performance of this pca is consistent with the existence of intermittent circuit connections.

Event Description

Original report - the patient reported that he was unable to interrogate his device after experiencing a fall.The neurostimulator was replaced on 1/16/23.A significant dent was noted on the top can of the neurostimulator when it was explanted.The neurostimulator was returned for investigation.Investigation results: testing confirmed an intermittent connection in the pca circuit.This pca was subjected to a severe impact transmitted from the device can through the internal frame.Most probably the impact to the pca cracked some number of solder ball connections between the sdbga and the pca or possibly traces in the pcb itself were compromised.The intermittent electrical performance of this pca is consistent with the existence of intermittent circuit connections.

• 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 ; 5108822607
• MDR Report Key: 16374661
• MDR Text Key: 309569317
• Report Number: 3004426659-2023-00003
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717201018
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RNS 320
• Device Catalogue Number: 1007694
• Device Lot Number: 29547-1-1-1
• Date Manufacturer Received: 10/30/2023
• 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): Hospitalization; Other
• Patient Age: 43 YR
• Patient Sex: Male