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

Model Number	71004
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat bilateral lower back pain.The system was activated on (b)(6) 2025 and several weeks later the patient reported having difficulty maintaining communication between the implantable pulse generator (ipg) and the external therapy discs.Reprogramming and troubleshooting was performed and unable to correct the problem.Imaging was performed by the medical office and the ipg was reported to have migrated beyond the recommended depth as well as rotating so that it was no longer seated parallel to the skin surface.On (b)(6) 2025 a surgical revision was performed to reposition the existing ipg so that it is more superficial and positioned parallel to the skin.
Additional Manufacturer Narrative
All original components remain implanted and in use after being repositioned, indicating that the communication issues noted are related to the position of the device and not the function of the components.There is no indication of any component failure or malfunction.The patient was initially able to successfully use the nalu system when it was activated, indicating that the implant of the device was within the recommended depth and the position was such that communication was able to be maintained.At some point after activating the system the ipg appears to have migrated.There are no reports of any falls or trauma that the patient sustained during the several weeks between activating the system and experiencing communication issues.It is possible that the patient was receiving pain relief and thus increased activity levels prematurely, before the implant had adequate scar tissue in place to maintain stability.It is also possible that the implant was placed in unstable tissue initially, allowing the component to migrate later.Migration of implanted components is a known inherent risk of neuromodulation systems.

• 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: 22671848
• Report Number: 3015425075-2025-00223
• Device Sequence Number: 18004557
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)241202(17)271202
• 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
• 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): 07/25/2025

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: 06/27/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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