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	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the revision procedure a nalu representative was present and performed a visual assessment of the explanted components along with the physician.The physician and the nalu representative were unable to identify any obvious visual issues with any of the components removed.The patient denies any falls or other events leading up to the loss of therapy.During the revision procedure the original leads were disconnected from the implantable pulse generator (ipg) and tested to identify if the impedance errors were related to the leads or the ipg.After disconnecting, both leads continued to return impedance errors, indicating that the leads were likely the source of the problem.The most common cause of the impedance errors in leads is a fracture within the lead.Although no visually obvious fractures were noted at the time of explant, it is possible that the internal wiring had sustained a small fracture and thus disrupted the circuit.The explanted components were not returned to the firm for further examination and testing.Loss of therapy is likely caused by a fracture to the implanted leads but cause of the lead fracture is unable to be identified with the information available.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024.On (b)(6) 2025, the patient noted that the system was no longer delivering therapy.Testing of the system while implanted found impedance errors on multiple contacts of both implanted leads.Xray imaging was performed but did not show any obvious issues.On (b)(6) 2025, a surgical revision was performed to replace the malfunctioning system.

• 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: 23740846
• Report Number: 3015425075-2025-00332
• Device Sequence Number: 10349921
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)240719(17)270719
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: 11/06/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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