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

Model Number	71019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician following this patient reported that the suspected cause of lead exposure after the initial implant was buildup of fluid in the area and not due to any issue with the lead itself.There are no reports of any infection and no reports of any issues with the nalu system at that time.The patient's healing process and body response to the surgical procedure appeared to be the cause of that issue.After repositioning the exposed lead, the patient had the system implanted and in use for approximately 8 months before experiencing skin redness and irritation.External factors were ruled out through troubleshooting, including use of topical barrier creams and removing the nalu adhesive clips for a time to allow skin healing.The patient had no fever or drainage at the site, no signs of infection, and continued to report approximately 80% pain relief from the system.The site of the irritation may have been related to the anchors used to secure the implanted leads, however this was unable to be confirmed.Cause of the skin irritation was not able to be identified with the available information.Although there is no evidence of any failure, malfunction, or user error as related to the nalu device itself, the cause of the irritation is unknown and thus this report is being filed out of caution.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat knee pain.After the system was implanted the patient experienced fluid buildup in the area of the incision, causing the implanted lead to be pushed up through the incision and become exposed.On (b)(6) 2025 the physician pushed the exposed lead back into place and closed the incision.Approximately 8 months after repositioning the exposed lead, the patient reported to the medical provider that they were experiencing redness and irritation around the lead entry incision site.Troubleshooting was performed however the irritation persisted and the patient elected to have the system removed.A full system explant was performed on (b)(6) 2026 per patient request.

• 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: 25356550
• Report Number: 3015425075-2026-00053
• Device Sequence Number: 16115514
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• UDI-Public: (01)00812537037196(11)241203(17)271203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2026
• 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): 06/01/2026

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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