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

Model Number	71020
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 a surgical procedure was initiated to implant a nalu peripheral nerve stimulator system.While in the procedure one of the nalu components intended to be implanted was found to be non-functional.The implantable pulse generator (ipg) was unable to communicate with the clinical programmer device and thus unusable.The malfunction was identified prior to implanting into the patient.A new ipg was introduced and the procedure was able to be successfully completed.
Additional Manufacturer Narrative
The allegedly malfunctioning ipg was not retained for testing by the firm, thus the cause of connectivity issues is unable to be identified.Intra-operative testing identified the issue prior to implanting the device.There are no reports of any significant delay to the procedure and no reports of any harm to the patient related to this case.

• 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: 50024550
• Report Number: 3015425075-2026-00069
• Device Sequence Number: 10540140
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)260220(17)290220
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 02/20/2026
• 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