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

Model Number RNS-320-K - FGI

Device Problem Premature Discharge of Battery (1057)

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

Event Date 07/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pending return of the explanted device for investigation of the actual device.Review of the manufacturing records show no defects identified during the production of the device, it has been manufactured and released per our specifications.Review of the device settings indicates that detection settings and high therapy rate contributed to the rapid voltage drop.

Event Description

Rns-320 serial # (b)(6).Implanted on (b)(6) 2021.On (b)(6) 2022 it was noted that the device experienced several abrupt battery drops and is now depleted.Review of the device battery plot suggested a possible early battery depletion.The neurostimulator was replaced on (b)(6) 2023.The neurostimulator is pending return to neuropace for investigation.

Manufacturer Narrative

(b)(4).Investigation results: review of the manufacturing records show no defects identified during the production of the device, it has been manufactured and released per our specifications.Review of the device settings indicates that detection settings and high therapy rate contributed to the rapid voltage drop.Investigation of the returned device found the device was subject to electrical overstress (high energy exposure) in the output stage (stim dac).The source of the electrical overstress is not known.

Event Description

Investigation results: original report: rns-320 serial # (b)(6) implanted on (b)(6) 2021.On (b)(6) 2022 it was noted that the device experienced several abrupt battery drops and is now depleted.Review of the device battery plot suggested a possible early battery depletion.The neurostimulator was replaced on (b)(6) 2023.The neurostimulator is pending return to neuropace for investigation.

• 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: 17515793
• MDR Text Key: 321074455
• Report Number: 3004426659-2023-00042
• Device Sequence Number: 1
• Product Code: PFN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 30667-1-1-1
• Date Manufacturer Received: 11/29/2023
• 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): Other; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male