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

Model Number	71019
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2022 to treat knee pain.In (b)(6) 2025 the patient was at an acute hospital for severe headaches, neck stiffness, and peripheral vision loss that is unrelated to the area being treated by the nalu device.Prior to being discharged from the hosptial the patient was ordered to have an mri.Pre-mri check of the nalu system found impedance errors on 5 contacts and the mri was not able to be completed.Review of records found impedance issues dating back to 2023, however there is no record of any complaints around efficacy of the nalu system and the patient reports that the pain symptoms nalu was intended to treat were no longer present and thus the system was not being used.At the time of the hospital admission the patient was unable to complete the ordered mri due to the impedance issues with the nalu system.The patient was ultimately discharged home and planned to remove the nalu system.The patient ceased communication with the nalu team and the firm was not consulted for any planned explant procedures.On (b)(6) 2025 a representative of the firm reached out to the physician to determine patient status and was informed on that day that an explant had been performed.The date of explant and details around the procedure were not shared.
Additional Manufacturer Narrative
Although the patient did not report any issues with the nalu system, the presence of open circuit impedance errors prevented the patient from undergoing diagnostic scans during an acute hospital admission.The most likely cause of the errors is a fractured lead or a fracture within the connector between the lead and the implantable pulse generator (ipg).The explant was performed without any nalu representative present and the explanted device was not retained for return to the firm, thus no further evaluation of the device is able to be performed to confirm a fracture.

• 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: 23687726
• Report Number: 3015425075-2025-00344
• Device Sequence Number: 17606000
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)220425(17)250425
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/01/2025

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: 04/25/2025
• 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: 11/19/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2022
• 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