MAUDE Adverse Event Report: Nalu Medical, Inc Nalu Neurostimulation System; Peripheral Nerve Stimulator

Model Number	72011
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator (pns) system in (b)(6)2025 and after several months of use the patient reported loss of therapy.Imaging was performed and found that the leads that had been placed to target the medial branch nerve had migrated away from the intended target location, causing the loss of therapy.Any surgical intervention to reposition or replace the leads was delayed due to the patient's cardiac health and lack of medical clearance for moving forward with the procedure.In july 2026 the patient was cleared for surgery and on (b)(6)2026 the original, non-tined system was removed and a new system utilizing tined style leads was placed, targeting the medial branch and medial cluneal nerves.
Additional Manufacturer Narrative
The original system implanted utilized non-tined leads with anchors and the new system utilized tined style leads with no additional anchors required.There are no reports of any issues with the structural tissue support at the site of the implant and no reports of any activites or events that may have contributed to lead migration.Migration is a known inherent risk of implantable neuromodulation systems and no further conclusions are able to be drawn with the information available.

• 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 -724
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008--724
• MDR Report Key: 50024258
• Report Number: 3015425075-2026-00064
• Device Sequence Number: 9616147
• Product Code: GZF
• UDI-Device Identifier: 00812537037226
• UDI-Public: (01)00812537037226(11)250129(17)280129(10)94582452X
• 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
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2026

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: 72011
• Device Catalogue Number: 72011
• Device Lot Number: 94582452X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 01/29/2025
• 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