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

Model Number	71019
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Rash (2033)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat hip pain.The implantable pulse generator (ipg) was placed in the lower back area with the implanted leads targeting the cluneal nerve.The patient was seen several times over the subsequent year for regular follow-ups with no reports of any issues with the nalu system.In (b)(6) 2025 a nalu representative was notified by the medical clinic that the patient had reported development of a rash on the skin over the distal end of the implanted leads.The patient was advised to stop using the system to see if the symptoms would resolve.The symptoms remained even with the system not in use and on (b)(6) 2025 a full system explant was performed.
Additional Manufacturer Narrative
There are no known medical or health issues present that may have caused the patient's symptoms.There is no known history of the patient having any reaction to or rejection of medical products.The skin irritation appeared directly over the distal end of the implanted leads and nowhere else on the patient's body, including the location of the adhesive clips that hold the nalu external components in place.The patient reported receiving good therapy from the system prior to explant and the system had been in use for more than a year before the symptoms began.Cause of the patient's skin symptoms is unknown and unable to be determined with the information available.

• 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: 23048216
• Report Number: 3015425075-2025-00279
• Device Sequence Number: 18651473
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)240305(17)270305
• 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
• 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): 09/14/2025

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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