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

Model Number	71019
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of implant a depth check was completed and found no issues, indicating the device was in an appropriate depth at that time.The reported symptoms were reported several months later and thus seem to indicate that the ipg had migrated.The ipg was initially implanted around the patient's waistline, but there is insufficient information to determine if that placement was appropriate when considering the patient's clothing position and tissue quality at the site.Migration is a known inherent risk of implantable neuromodulation devices and there is insufficient information in this case to point to any other contributing factors for the migration.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025, targeting bilateral superior cluneal nerves.Approximately 3 months after the implant was performed, the patient noted challenges maintaining connectivity between the implantable pulse generator (ipg) and the external therapy discs.A nalu representative assessed the system and reported that the ipg was difficult to palpate, indicating it had likely migrated beyond the recommended depth for optimal connectivity.On (b)(6) 2026, a surgical revision was performed to remove the migrated system and place a new system at a more superficial position.

• 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: 50024266
• Report Number: 3015425075-2026-00066
• Device Sequence Number: 15890742
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• 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: 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: 71019
• Device Catalogue Number: 71019
• 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: 03/20/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 10/28/2024
• 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