MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	71007
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no allegations of system or component failure or malfunction.Patient requested a specific location for implant and was dissatisfied with the location the physician chose to implant.During the initial implant procedure, the physician elected to place the ipg in a location that would provide the best possible function of the system based on the patient's anatomy.The initial surgical revision was performed per the patient request and placed the ipg at the patient's requested location.The location requested by the patient was found to not be optimal for function of the system due to the patient's anatomy.The communication issues encountered are directly related to the patient choice of location for the ipg despite being advised against the location.
Event or Problem Description
Patient was implanted with nalu peripheral nerve stimulator system on (b)(6) 2022.Patient had expressed a preferred location for the implant, however during the procedure the physician made the determination that an alternate location would be better suited to the patient's physical anatomy.Patient contacted nalu to express dissatisfaction with the location of the implant and requested to have it moved to the originally requested location.Surgical revision was performed on (b)(6) 2023 to move the implantable pulse generator (ipg) to the patient's requested location.No new components were implanted at the time of the procedure.See mdr 3015425075-2023-00056.After moving the ipg to the patient's requested location, the patient found that there were issues with communication between the ipg and the external therapy discs.The patient expressed frustration and requested to remove the nalu system.On (b)(6) 2025 a surgical procedure was performed to remove the nalu ipg.The nalu leads remain implanted and were connected to a device from a different manufacturer.

• 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 7241
• Manufacturer Contact: chelsea gutierrez ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7144010608
• MDR Report Key: 22200124
• Report Number: 3015425075-2025-00185
• Device Sequence Number: 18059300
• Product Code: GZF
• UDI-Device Identifier: 00812537030999
• UDI-Public: (01)00812537030999(11)210714(17)240714
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2025

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 Expiration Date: 07/14/2024
• Device Model Number: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2021
• 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