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

Model Number	71007
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of records found no history of any complaints from this patient around function or efficacy of the nalu system, however the physician shared that the system was not effective in addressing the patient's pain, leading to the request for explant.The physician did not share any further information around troubleshooting performed prior to explant and there are no records on file indicating that any nalu representative had been contacted for troubleshooting or system assesment.The information available is insufficient to draw any conclusions around reason for the lack of efficacy of the nalu system.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat foot pain.Approximately 1 year after implanting the system, in (b)(6) 2025, the patient requested to have the system removed.No explanation was provided as to why the request was made and there was no further communication from the patient or physician.On 10/10/2025 a nalu representative reached out to the physician for an update on the patient's status and was informed that the nalu system had already been removed.Date of explant was not provided.

• 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: 23334091
• Report Number: 3015425075-2025-00305
• Device Sequence Number: 13248910
• Product Code: GZF
• UDI-Device Identifier: 00812537036144
• UDI-Public: (01)00812537036144(11)230921(17)260921
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/19/2025

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 Expiration Date: 09/21/2026
• Device Model Number: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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