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

Model Number	71019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system in idaho on (b)(6) 2024 to treat lower back pain.After implanting the system, the patient was seen several times by local nalu representatives for typical system reprogramming.During those appointments the patient had expressed inadequate relief which was attempted to be addressed through programming.After the implant and several reprogramming sessions, the patient relocated to a different state and was no longer in contact with nalu personnel.In december 2025 the firm was notified by a medical facility in arizona that the patient was scheduled for explant of their nalu system.A full system explant was performed on (b)(6) 2026 as planned.Scheduling conflicts prevented any nalu personnel from being present for the procedure and the explanted components were not retained for return to the firm.
Additional Manufacturer Narrative
After the patient left the state where the implant took place, there was no further communication with nalu to perform any system troubleshooting or additional reprogramming.There are no records of any system or component failure or malfunction and no reports of any suspicion of migration or malposition.It is unclear with the information available if the patient was not receiving appropriate stimulation or if stimulation was appropriate but failed to meet the patient's expectations.

• 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: 24341649
• Report Number: 3015425075-2025-00380
• Device Sequence Number: 18560423
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• UDI-Public: (01)00812537037196(11)240607(17)270607
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2026
• 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): 02/15/2026

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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