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

Model Number	72006
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Balance Problems (4401)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the system during activation suggested that the leads had possibly migrated, however no imaging was made available to confirm initial implant location vs location of the leads at activation.The patient verbally expressed frustration with post-op instructions, including the need to minimize movement in the neck area to allow the site to heal and scar tissue to form around the device for stability.Based on patient response, it is unclear if the patient was compliant with the instructions and potential noncompliance may have contributed to movement of the implanted components.It is possible that a combination of lead placement and stimulation levels may have contributed to the patient's complaints of feeling unstead or off balance, however the more likely cause of symptoms is that the patient has other underlying health conditions.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 with the system being activated on (b)(6) 2025.During activation of the system, it was noted that the patient was not receiving adequate therapy to the desired location.In (b)(6) 2025 the patient reported that therapy was not providing any relief and that the stimulation was causing the patient to feel off balance.A full system explant was performed on (b)(6) 2025 per the patient's 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: 22989070
• Report Number: 3015425075-2025-00267
• Device Sequence Number: 9257512
• Product Code: GZF
• UDI-Device Identifier: 00812537037370
• UDI-Public: (01)00812537037370(11)250210(17)280210(10)9458622
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/06/2025

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: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 9458622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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