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

Model Number	71004
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 the patient was implanted with a nalu peripheral nerve stimulator system after having participated in a successful trial phase with nalu.After using the nalu system for nearly a full year, the patient reported issues with communication and was seen in the medical office for a follow-up.The placement of the implantable pulse generator (ipg) was noted to be near the area on the lower back where the patient wears their pants, thus causing some challenges with placement of the external components and likely being the cause of the communication issues noted.On (b)(6) 2025 a surgical procedure was performed to reposition the ipg to a more usable location on the lower back.
Additional Manufacturer Narrative
There are no indications of any system or component failure or malfunction leading up to the surgical procedure.The patient participated in a trial with nalu prior to implanting the permanent system.During the trial the patient would have participated in identifying a comfortable position for the external components.It is likely that the ipg was placed just slightly off from the patient's chosen location, causing interference with the patient's clothing.No components were removed or replaced during the surgical procedure and all original implanted components remain implanted and in use after repositioning.

• 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: 22709957
• Report Number: 3015425075-2025-00238
• Device Sequence Number: 8911745
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)231024(17)261024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/04/2025

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: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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