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

Model Number	72006
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reported or known events leading up to the change in therapy.The patient is reported to appear healthy and with good tissue quality at the implant site.The original and revised system used tined leads, thus no additional anchors or sutures were used.Migration is a known inherent risk of implantable neuromodulation systems and there does not appear to be any other extenuating factors contributing to device movement.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 with the system targeting the medial branch nerve.On (b)(6) 2025, the patient reported some discomfort, noting that stimulation from the nalu system seemed to be felt beyond the intended target area.The patient was seen in the medical clinic and xray imaging confirmed one of the leads had migrated away from the original implant location.The system was reprogrammed to use only the single lead that was not causing discomfort; however, use of the single lead was not able to provide sufficient pain relief for the patient.On (b)(6) 2026, the patient was seen for surgical revision to replace the migrated lead.During the procedure the implantable pulse generator was also replaced out of caution.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7144010608
• MDR Report Key: 24971728
• Report Number: 3015425075-2026-00051
• Device Sequence Number: 20072276
• Product Code: GZF
• UDI-Device Identifier: 00812537037387
• UDI-Public: (01)00812537037387(11)240807(17)270807(10)9457631
• 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: 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): 04/23/2026

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: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 9457571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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