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

Model Number	71004
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgical procedure was performed to reposition an implantable pulse generator (ipg) due to issues with intermittent connectivity between the ipg and the external therapy discs.During the procedure the original ipg was moved to a different pocket to correct the connectivity issues.All original components remain implanted and in use after the procedure.
Additional Manufacturer Narrative
The system had been in use for several months before the patient reported connectivity issues.The original component was repositioned only, indicating that the component continues to function as expected and position of the component is the likely cause of the symptoms reported.Symptoms were not present at the time of implant, indicating the ipg likely migrated to a sub-optimal 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: 50746887
• Report Number: 3015425075-2026-00110
• Device Sequence Number: 21372292
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)241028(17)271028
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2026

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
• Operator of Device: Lay User/Patient
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/13/2026
• 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