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	07/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient has a history of diabetes and very high bmi, possibly contributing to a failure to heal.It is unclear if the flu symptoms reported were due to infection or if the patient was ill and this contributed to poor healing at the incision.No lab cultures were taken on (b)(6) 2025 and any results of post-explant cultures have not been made available to the firm.Source of infection is unknown.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower extremity pain.The implantable pulse generator (ipg) was placed in the patient's calf area with the implanted leads targeting the common peroneal nerve.On (b)(6) 2025 the patient began a regimen of antibiotics to treat reported flu-like symptoms.On (b)(6) 2025 the patient notified the firm that the surgical incision site appeared to be red and irritated and the patient was concerned about infection.The patient was prescribed a different antibiotic and instructed to present at the surgery center the following day.On (b)(6) 2025 a full system explant was performed due to the possible 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: 22683274
• Report Number: 3015425075-2025-00230
• Device Sequence Number: 18503549
• Product Code: GZF
• UDI-Device Identifier: 00812537036144
• UDI-Public: (01)00812537036144(11)240207(17)270207
• 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): 07/31/2025

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: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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