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	Inadequate Pain Relief (2388)
Date of Event	07/20/2026
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 cluneal nerve.After using the system for some time the patient then reported challenges connecting the implantable pulse generator (ipg) to the external therapy discs.Troubleshooting in the field confirmed the external devices to be functioning as expected and found no impedance errors when the system was tested while implanted.Fluoroscopic imaging was completed to rule out ipg migration as a cause of the connectivity issues.Cause of the connectivity issues was unable to be identified so the patient was scheduled for revision of the ipg.On (b)(6) 2026, a surgical procedure was performed to reposition the ipg, however after handling the device it returned impedance errors and required replacement during the same procedure.The implanted leads remained in place and were successfully connected to the new ipg.
Additional Manufacturer Narrative
The nalu representative present at the revision confirms there are no reports of any events leading up to the change in connectivity and imaging did not identify any implanted device migration.Impedance testing returned all good readings before revision and then impedance errors after removing the ipg from the pocket.There is insufficient information or testing to verify if the impedance errors were due to device failure or related to handling damage from the revision procedure.The explanted ipg was not retained for return to the firm and thus no further testing was able to be performed to draw any conclusions as to the cause of the connectivity challenges.

• 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: 50136206
• Report Number: 3015425075-2026-00072
• Device Sequence Number: 16071806
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)251120(17)281120
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/04/2026

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: 07/20/2026
• Initial Report FDA Received Date: 08/04/2026
• Date Device Manufactured: 11/20/2025
• 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