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

Model Number	71019
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 after participating in a successful trial phase with nalu.Testing was performed intra-operatively to assure placement and function of the nalu system.After using the system for some time, the patient reported not getting the relief being sought despite multiple attempts to reprogram and troubleshoot.Xray imaging confirmed all implanted components appeared to be in the correct position, showing no signs of migration or damage.On (b)(6) 2025, a full system explant was performed per the patient's request, due to lack of pain relief.
Additional Manufacturer Narrative
The patient initially reported approximately 50% pain relief with activity levels being much improved.Troubleshooting and imaging done prior to explant did not identify any issues with function of the nalu system.Imaging showed no signs of damage or movement of any implanted components.It is probable that the cause of the patient's pain symptoms continued to evolve after the implant and the nalu system was no longer adequate relief for the progressing issue.The explanted device was not released by the medical facility and thus is not available for testing to confirm function, thus the conclusions drawn are based on pre-explant testing of the system.

• 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: 22696365
• Report Number: 3015425075-2025-00232
• Device Sequence Number: 9143395
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)240111(17)270111
• 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: 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): 08/01/2025

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 08/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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