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 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a routine follow-up, the patient reported having issues in the last couple of months with interrogating at home.Multiple attempts were made to interrogate the device using different programmers and wands, all attempts were unsuccessful.The rns provided no signal when attempting to interrogate.The device appears to be nonfunctional.The patient's mother reported that the patient had a fall in (b)(6) or (b)(6) 2022, resulting in the patient hitting his head on a wall.The patient did not go to the hospital, nor have any imaging or surgery after the fall.The rns was replaced on 08 nov 2022.

• 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: 16559874
• MDR Text Key: 311686107
• Report Number: 3004426659-2023-00012
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717201001
• 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
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: 29298-1-1-1
• Date Manufacturer Received: 11/08/2022
• 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): Required Intervention; Other
• Patient Age: 27 YR
• Patient Sex: Male