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

Model Number	71004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2026 to treat shoulder pain.The implantable pulse generator (ipg) was placed in the posterior shoulder area with the leads targeting the suprascapular nerves.After using the system for several months the patient elected to move forward with surgery to the shoulder being treated by the nalu system.In preparation for the planned procedure, the nalu system was surgically explanted on (b)(6) 2026 per patient request.
Additional Manufacturer Narrative
Review of records found no history of any complaints regarding the nalu system, any of its components, or quality of therapy.Reason for the planned shoulder surgery was not shared with the firm.A separate procedure was required to remove the nalu system while preparing for the procedure.

• 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: 50184722
• Report Number: 3015425075-2026-00078
• Device Sequence Number: 18644093
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)250506(17)280506
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/08/2026
• Date Device Manufactured: 05/06/2025
• 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