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

Model Number	72006
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient is reported to be very active with activities such as traveling, hiking, and hunting, however there are no specific events or activities that coincide with the reduction in therapy.The most likely cause of the impedance issues and subsequent change in therapy is a fracture of an internal component.The malfunctioning tined leads were unable to be removed during the revision procedure and remain implanted in the patient, thus there is no further evaluation that is able to be performed on the components themselves to further confirm the presence or location of a fracture.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat knee pain.Approximately 2 months after implant the patient reported a decline in therapy.The patient was seen for reprogramming and troubleshooting and it was discovered that one of the implanted leads had bad impedance readings on all electrodes and the second lead had bad impedance readings on 2 out of 4 electrodes.On (b)(6) 2025 a surgical revision was performed to remove the malfunctioning leads and place new leads.During the procedure the implantable pulse generator (ipg) was also replaced out of caution.

• 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: 24114337
• Report Number: 3015425075-2025-00349
• Device Sequence Number: 21256896
• 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: AZ
• 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): 01/05/2026

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: 6458622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/20/2026
• 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