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

Model Number	71007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat foot pain.At the time of the initial system activation the patient reported good healing and receiving 100% pain relief from the system.On (b)(6) 2025 the patient noticed some redness and discomfort at the incision site for the implantable pulse generator (ipg).Patient was evaluated by the primary doctor (not the implanting doctor) and informed an infection may be developing.The primary doctor cleaned the site and prescribed oral antibiotics.After being seen by the primary doctor, the patient then notified the implanting doctor of the possible infection.The implanting doctor advised to remove the system and culture to determine infection type.On (b)(6) 2025 the ipg was removed, however the doctor was uncomfortable removing the leads as they were scarred in close proximity to the tibial nerve.
Additional Manufacturer Narrative
The patient is 86 years old and has a history of cancer as well as other underlying health issues, the specifics were not shared.A culture was taken at the time of ipg explant.The explant results were not made available to the firm however the patient reports presence of two types of bacteria (unknown what types).The patient had initially appeared to be healing well and approximately one month after the procedure noticed the first signs of infection.Infection is a known inherent risk of invasive procedures and it is unknown if or how the patient's pre-existing health conditions may have contributed.

• 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: 24393123
• Report Number: 3015425075-2025-00361
• Device Sequence Number: 10257863
• Product Code: GZF
• UDI-Device Identifier: 00812537037356
• UDI-Public: (01)00812537037356(11)240801(17)270801
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/26/2026

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: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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