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

Model Number RNS-320-K - FGI

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

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted device  was returned to neuropace and is undergoing analysis.

Event Description

Rns-320 serial # (b)(6) implanted (b)(6) 2020 (2.61 yrs).On (b)(6) 2023, the patient reported difficulty interrogating her rns.Review of the device battery plot suggested a possible early battery depletion.The neurostimulator was explanted and replaced on (b)(6) 2023.The neurostimulator was returned to neuropace for investigation on (b)(6) 2023.

Manufacturer Narrative

(b)(4).The explanted device was received with a significant puncture which penetrated the outer can.The surgeon reportedly used forceps during explant, resulting in damage of the device and the battery.The puncture potentially allowed body fluid to have entered, compromised and contaminated the internal components.Neuropace was thus, unable to investigate the returned the device.

Event Description

Investigation results are provided in section h6.Original report - rns-320 serial # (b)(6) implanted (b)(6) 2020 (2.61 yrs.).On (b)(6) 2023, the patient reported difficulty interrogating her rns.Review of the device battery plot suggested a possible early battery depletion.The neurostimulator was explanted and replaced on (b)(6) 2023.The neurostimulator was returned to neuropace for investigation on 13 jul 23.

• 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
• MDR Report Key: 17398009
• MDR Text Key: 320163486
• Report Number: 3004426659-2023-00033
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617230913
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RNS-320-K - FGI
• Device Catalogue Number: 1007927
• Device Lot Number: 30248-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• 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): Other; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female