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

Model Number	71019
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat lower back pain.After using the system for an unspecified time frame, the patient reported reduction in therapy.The patient reported that the system had initially addressed the areas of pain but then later stimulation was no longer felt in those same areas.Imaging was performed and confirmed the implanted leads had migrated.On (b)(6) 2025 a surgical revision was performed to remove the migrated leads and place new leads back at the desired nerve target to address the patient's pain location.The original implantable pulse generator (ipg) remains implanted and in use with the new leads.
Additional Manufacturer Narrative
There is no information made available to the firm around any events leading up to the change in therapy and the date the change was first noted is unknown.The information available does not allow for any further conclusions to be drawn around any potential causes of lead migration.

• 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: 23306095
• Report Number: 3015425075-2025-00302
• Device Sequence Number: 4955025
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)230818(17)260818
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 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): 10/15/2025

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: 08/18/2026
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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