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

Model Number	71004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	02/20/2025
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 after participating in a successful trial phase to treat lower extremity pain.The implantable pulse generator (ipg) was placed in the lateral thigh area of the left leg, with the leads targeting the sciatic nerve.The system was successfully activated with no issues.On (b)(6)2025 a nalu representative spoke with the patient about scheduling a visit for reprogramming.The patient did not report any concerns during that conversation.On (b)(6)2025 the firm was notified that the patient arrived at a local emergency department (ed) via ambulance on (b)(6)2025 with complaints of extreme pain in the left upper leg.Intake assessment at the ed identified a softball size abscess on the upper thigh near the location of the nalu insertion site.The abscess was confirmed via ct scan.The implanting physician was contacted and agreed with the ed physician that the nalu system would be removed.The patient was admitted to the acute facility for iv antibiotics and a full system explant was performed on (b)(6)2025.The incisions were irrigated upon explant and the patient remained on antibiotics.
Additional Manufacturer Narrative
The patient did not show any outward or visible signs or symptoms of infection during activation of the nalu system.The patient did not report any signs or symptoms of infection when contacted by nalu within 24 hours prior to arriving at the ed.Patient reports that the symptoms came up very quickly and denies any open wounds, previous infections, falls, or other external trauma to the site.It was noted by the implanting physician that the patient had high blood sugar upon arrival at the ed and the physician suspects the patient may have undiagnosed diabetes, which may contribute to poor healing after surgical procedures.Lab cultures were not made available to the firm to identify the type of infection involved.Infection is a known inherent risk of surgical procedures and in this case may have been exacerbated by suspected underlying health conditions.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21671728
• Report Number: 3015425075-2025-00091
• Device Sequence Number: 12805856
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)230505(17)260505
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/22/2025

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 Expiration Date: 05/05/2026
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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