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

Model Number	71020
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2026 targeting the medial branch nerve.The patient had previously participated in a successful trial phase with nalu.After implanting the system the patient exhibited difficulty in utilizing the external components, requiring multiple re-education sessions regarding how to place the therapy disc over the implantable pulse generator (ipg) and how to charge the therapy disc.The patient repeatedly provided conflicting reports regarding effectiveness of the therapy, resulting in multiple reprogramming sessions with nalu representatives.The patient ultimately requested to have the system removed, citing potential for mri needs at some point in the future.As the patient had an existing scs system in place, the dual systems would prevent mri scans if needed.At the time of the request there were no known planned mri needs and the rationale for explant was theoretical.On (b)(6) 2026 a full system explant was performed per patient request.
Additional Manufacturer Narrative
The patient was seen by nalu representatives multiple times during the 6 months the system was implanted and there was no evidence of any system or component failure or malfunction reported from any of those visits.The patient is reported to struggle with using the nalu system and this was thought to be related to some apparent memory challenges.The patient was educated multiple times on use of the system and reports from the patient around effectivity varied, sometimes on a week to week basis.Although the nalu system appears to have been functioning as designed, the system was not able to be effectively used by this patient.

• 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: 50024271
• Report Number: 3015425075-2026-00067
• Device Sequence Number: 9751904
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• 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: 2026
• 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: 71020
• Device Catalogue Number: 71020
• 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: 05/27/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 10/03/2025
• 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