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	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
When the patient requested for the nalu system to be explanted, the patient was offered multiple options for troubleshooting, including reprogramming, education, and alternative external wearables to attemp to improve usability and efficacy of the system.The patient was adamant about not participating in any of the options provided.Patient reported being unhappy with charging of the external battery and the function of the adhesive clips to hold the external battery, although both of those aspects were present during the trial phase and should have been well understood prior to moving forward with the permanent implant.The patient reported at that time that neither the trial or permanent system had ever provided adequate relief.Review of patient history found that intra-operative testing was performed during the implant of the permanent system and returned appropriate readings and stimulation location.The patient was seen multiple times between (b)(6) 2025 for system reprogramming but continued to report poor efficacy of therapy.No suspicion of any system or component failure was identified during any of the reprogramming sessions.No reports were received of stimulation being delivered to an incorrect area, seeming to indicate that the system had not migrated.The explanted system was not returned to the firm for any further testing or investigation.Reason for the reported lack of efficacy is unknown and unable to be determined with the information available from interviews and system programming and troubleshooting performed prior to explant.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower back pain.All records appear to indicate that the trial phase with nalu was successful, leading to implant of a permanent system.On (b)(6) 2025 the patient reported to a nalu representative that the system had not been used since approximately (b)(6) 2025 due to dissatisfaction with usability and therapy being received and the patient requested to have the system removed.On (b)(6) 2025 a full system explant was performed.

• 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: 22768326
• Report Number: 3015425075-2025-00244
• Device Sequence Number: 13114517
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• UDI-Public: (01)00812537037196(11)240716(17)270716
• 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: 2025
• 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): 08/10/2025

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: 07/25/2025
• Initial Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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