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

Model Number	71004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 targeting the cluneal nerve to treat hip pain.After activation of the system, the patient reported difficulty maintaining connection between the implantable pulse generator (ipg) and the external therapy discs, especially when changing body positions.On (b)(6) 2023 a surgical revision was performed to place a new ipg in a more optimal anatomical position to reduce the connectivity issues related to change of positioning.See mdr 3015425075-2023-00318.In (b)(6) 2026 the firm was notified that the patient was experiencing inadequate pain relief and ineffective therapy from the system and was requesting to have it removed.A full system explant was performed on (b)(6) 2026 per the patient's request.
Additional Manufacturer Narrative
All explanted components were retained or discarded by the medical facility and thus unavailable for testing by the firm.Throughout the 2 years between revision and explant there was no communication to the firm from the patient or physician around any issues with the nalu system until approximately 10 minutes prior to the planned explant.A nalu representative provided explant guidance via phone call prior to the procedure and was given very high level explanation as to the reason for the system removal.It is unknown what imaging or other troubleshooting methods were used prior to scheduling an explant.The patient's health and physical condition are unknown and unable to be assessed as no nalu personnel were able to be present for the explant with the lack of prior notification.

• 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: 24683683
• Report Number: 3015425075-2026-00036
• Device Sequence Number: 9976607
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)210608(17)240608
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• 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): 03/20/2026

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 Expiration Date: 06/08/2024
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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