MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number	71004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The recommendation from the firm is to perform surgical intervention to replace the potentially malfunctioning device, however the plan of care is not yet determined at the time of the inital reporting.While there are no reports of any life threatening or serious injury having occurred, the firm is choosing to file an mdr out of an abundance of caution with the patient choosing to continue to utilize the system, along with the recommendation for surgical intervention.This appears to be an isolated event and there is no indication of any other similar devices from nalu being implicated based on the initial investigation.
Event or Problem Description
The patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2023 to treat upper leg pain.The implantable pulse generator (ipg) was placed in the lower back area with the leads targeting the t8-t10 area of the thoracic nerve.Approximately mid year in 2024 the patient was involved in an auto accident, resulting in an sacroiliac joint fusion.Initially after the auto accident the patient was experiencing very high levels of pain and was unable to use the nalu system.After the joint fusion, the patient's pain symptoms in that are were reported to be significantly reduced and the patient began to use the nalu system again in (b)(6) 2024 with good results.In (b)(6) 2025 the patient reported sensation described as sharp jolts at the location of the nalu ipg.The sensations were reported to be occurring several times throughout the day.Symptoms were reported to have started approximately (b)(6) 2025 despite running the same programs for the prior 6 months.Programming was adjusted to reduce threshold but patient was not getting adequate therapy from the new programming and elected to resume use of previous programs despite the jolting sensations.Imaging was performed and found no visual evidence of any system or component damage and no signs of migration.Impedance testing returned good results.Per the patient, there are no notable changes in activity levels and no reports of specific events that may have caused any damage to the implanted components.The patient is noted to have lost weight recently, although it is unknown if the weight change is relevant to the symptoms.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• 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: 22768334
• Report Number: 3015425075-2025-00252
• Device Sequence Number: 9585508
• Product Code: GZB
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)220224(17)250224
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/10/2025

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: 02/24/2025
• 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: 07/25/2025
• Initial Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2022
• 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