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

Model Number	71005
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no indications of any system or component failure or malfunction as all components remain implanted and in use.The connectivity challenges began within a month of implant and there are no reports of any events taking place after the implant that are likely to have contributed to device movement.Migration is a known inherent risk of implantable neuromodulation devices.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2026 to treat lower back pain.After activating the system, the patient reported some challenges in maintaining connection between the implantable pulse generator (ipg) and the external therapy discs.A nalu representative met with the patient on (b)(6) 2026 to assess the system.Imaging performed during the assessment confirmed the ipg had migrated within the pocket to no longer be seated flat and parallel to the skin surface.On (b)(6) 2026 a surgical procedure was performed to reposition the ipg into a new pocket so that it was parallel to the skin to correct connectivity issues.

• 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: 24723461
• Report Number: 3015425075-2026-00029
• Device Sequence Number: 18676846
• Product Code: GZF
• UDI-Device Identifier: 00812537037189
• UDI-Public: (01)00812537037189(11)241203(17)271203
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/26/2026

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: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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