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	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of the initial implant the nalu representative attending the procedure reports that both the ipg and the leads were sutured into place and there were no concerns around the implant procedure or techniques.The patient is noted to have good tissue quality at the implant site to support the device.There are no events leading up to the change in connectivity and the patient was reported to have been compliant with post-implant recovery instructions.No specific reason has been identified for the ipg to have moved.Migration is a known inherent risk of implantable neuromodulation systems.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat back pain.After activating the system, the patient later reported some difficulties maintaining connection between the implantable pulse generator and the external therapy discs.Assessment while the device remained implanted determined that the ipg had migrated beyond the recommended depth for optimal connectivity and had also rotated to no longer be seated parallel to the skin surface.Various methods of external device fixation were attempted as troubleshooting and failed to improve the connectivity between devices.On (b)(6) 2026, a surgical revision was performed to remove the migrated system and place a new nalu system at the intended nerve target and with the ipg placed superficially and parallel to the skin surface.

• 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: 24722348
• Report Number: 3015425075-2026-00035
• Device Sequence Number: 10133260
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)250227(17)280227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/27/2026

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: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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