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

Model Number	71020
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nalu device is reported to have been functioning well and providing good therapy when connected and all original components remain implanted and in use after being repositioned.The physician determined that the initial orientation of the ipg allowed the device to shift with the surrounding tissue and thus required repositioning to achieve better stability and consistent connectivity.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat back pain.After activating the system, the patient reported challenges with maintaining connection between the implantable pulse generator (ipg) and the external therapy discs.Specifically, the patient noted connectivity was achieved only in certain positions and would disconnect upon changing positions.Assessment in the field determined that the ipg was tilting or rolling with the surrounding tissue in the myofascial plane as the patient moved.On (b)(6) 2026 a surgical procedure was performed to remove the existing ipg and reposition it to a different orientation to avoid any shifting with patient movement.The patient reported resolution of symptoms after the procedure.

• 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: 24541138
• Report Number: 3015425075-2026-00018
• Device Sequence Number: 21414036
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)250825(17)280825
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/06/2026

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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