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

Model Number	71019
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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) 2021 to treat lower back pain.The system was activated and in use, however in 2023 the patient stopped seeing the physician that had implanted the nalu device and ceased communication with anyone from the nalu firm.In august 2024 the firm was notified that the patient was requesting an explant.The explant procedure was scheduled, but then cancelled for an unknown reason.The patient's new physician stated the patient had stopped using the nalu system and the physician requested for the patient to meet with a nalu representative and try using the system again.When scheduling the reprogramming, the nalu representative discovered that the patient would require new therapy discs.Apparently, the patient had become frustrated the prior year with the system due to the adhesive clips, but did not inform the local rep of the issue.Patient stopped using the system and discarded the therapy discs due to that frustration.Patient was issued new therapy discs and reprogramming was completed in (b)(6) 2024.The system appeared to be functioning well but the patient reported frustration with using the device.Per the patient, the discs were not staying adhered for as long as expected.Patient has mobility issues which cause the use of non-adehsive tools to hold the therapy discs to be uncomfortable.Patient also reported living alone and not having assistance with disc placement.In (b)(6) 2024 the patient again became unresponsive to nalu communication.In (b)(6) 2025 the patient was again scheduled for explant and the procedure took place on (b)(6) 2025.
Additional Manufacturer Narrative
Patient has a history of cervical and lumbar fusions and had been informed by a pain doctor that a combination of the nalu stimulator, medications, injections, and physical therapy would be likely be required in order to control pain.Patient has reportedly seen three different pain management physicians and appears to be unsatisfied with any of the solutions given.Patient is no longer seeing the physician that implanted the nalu device and has been sporadically responsive to multiple communication attempts from the nalu representatives.It appears there is some usability issues with the adhesive clips for the nalu external components, however the exact nature is unknown and troubleshooting has not been performed due to lack of patient cooperation and responsiveness.During reprogramming that took place in (b)(6) 2024 it appeared that there were no failures or malfunctions of the nalu system or any of its components.It is unclear if the patient's reason for not using the system is solely based on the usability of the external components or if the patient also has some frustration or dissatisfaction with having to continue to utilize a combination of pain control methods.

• 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: 21669750
• Report Number: 3015425075-2025-00087
• Device Sequence Number: 8228536
• Product Code: GZF
• UDI-Device Identifier: 00812537035604
• UDI-Public: (01)00812537035604(11)210512(17)240512
• 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: 2021
• 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): 03/21/2025

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: 05/12/2024
• 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: 02/20/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• 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