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

Model Number	71020
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	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no known lab cultures to confirm presence or type of infection present.The infection was not reported to have developed until approximately (b)(6) 2026, likely indicating that the infection was related to the incision site remaining open rather than related to the surgery or nalu device.The patient's pre-existing or underlying health conditions are unknown; thus, it is unknown if there are conditions that may have contributed to poor healing of the surgical site.There are potential concerns reported around the patient's wound care with keeping the site clean and dry to promote healing.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat back pain.The incision site failed to properly heal within the expected timeframe, causing a delay in activating the system.When approved, the system was activated for a short time before the incision site again displayed signs of poor healing.After a lengthy struggle with an open incision site, the patient also developed infection at the site and the physician advised removal.On (b)(6) 2026 a full system explant was performed due to ongoing healing issues as well as presence of infection.

• 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: 24761459
• Report Number: 3015425075-2026-00046
• Device Sequence Number: 9248666
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)250328(17)280328
• 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: 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): 04/01/2026

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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