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

Model Number	71004
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient did not report any significant events that took place after implanting the right-side system that may have caused or contributed to failure of the implanted components.The system was tested during the implant procedure and returned all good impedance readings at that time.The leads were reported to have been very superficial and it is unclear if or how the development of a hematoma may have impacted the implanted components.During troubleshooting of the right-side system, a nalu representative also assessed and reprogrammed the left side system and received verbal report from the patient of satisfaction with that system and therapy being received.The patient later stated to the medical staff that neither system was providing relief and had requested both be removed.The most likely cause of open circuit impedance readings in the right-side system is a fracture of either the lead itself or at the connector between the lead and the ipg.There are no known issues with the left side system and no issues or symptoms were shared with the firm until after the system was explanted.Both explanted systems were discarded at the time of the explant and are unavailable for any further assessment or testing.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator (pns) system on (b)(6) 2024 to treat left lower extremity pain and a second pns system was implanted (b)(6) 2025 to treat right lower extremity pain.After implanting the second system the patient developed a large hematoma at the implant site, which caused a delay in activation of the system.When attempting to activate, the system returned open circuit impedance readings and was unable to deliver therapy.Troubleshooting was performed and unable to resolve the issue.The patient ultimately requested to remove the system due to the lack of therapy.On (b)(6) 2025 the patient was seen for explant of the nalu system from the right lower extremity.No representatives from nalu were present for the explant procedure.After the procedure took place, the firm was notified that both nalu systems had been fully removed at the same time on 11/14/2025 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: 23739130
• Report Number: 3015425075-2025-00331
• Device Sequence Number: 15662325
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)241028(17)271028
• 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): 12/07/2025

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: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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