MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	71020
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the reprogramming sessions that were conducted during the year the nalu system was implanted, the system appeared to be functioning as expected with no signs of migration or impedance issues.Ultrasound and fluoroscopic imaging were used during the implant procedure to assure appropriate placement of the device to target the sural nerve and there are no reports of stimulation being received to an incorrect location.Patient initially reported fairly significant reduction in pain symptoms.No device failure or malfunction has been identified, and the cause for patient's subsequent perceived lack of effect is undetermined.
Event or Problem Description
The patient participated in a trial phase with nalu before being implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat foot pain.During the trial phase the patient had noted that the placement of the leads did not cover the entire foot, however chose to move forward with the permanent implant as the amount of coverage being recieved was satisfactory for the patient.The permanent system was implanted using both ultrasound and fluoroscopy to assure appropriate placement.The system was activated on (b)(6) 2024 and a follow-up programming session was performed on (b)(6) 2024.During the follow-up session the patiet reported reduction in pain symptoms from 8/10 down to 3/10.In (b)(6) 2025 the medical office notified a nalu representative that the patient was requesting to remove the nalu system due to lack of sufficient pain relief.The patient had been seen multiple times over the course of the year that the system was implanted and multiple reprogramming sessions had been performed to improve therapy and coverage, however the patient ultimately decided that coverage was insufficient.A full system explant was performed on (b)(6) 2025 per the patient's request.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: chelsea gutierrez ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7144010608
• MDR Report Key: 22881254
• Report Number: 3015425075-2025-00264
• Device Sequence Number: 9971678
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)231115(17)261115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown