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

Model Number	71007
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator on (b)(6) 2023 to treat lower extremity pain post amputation.The implantable pulse generator (ipg) was placed in the lateral thigh area with the implanted leads targeting the sciatic nerve.The nalu system was implanted to replace an existing system from a different manufacturer.After the implant, the patient consistently reported minimal pain relief from the nalu system despite multiple reprogramming sessions.On (b)(6) 2025 a surgical revision was performed to place a second lead to better achieve pain relief.The ipg that was originally implanted did not accommodate dual leads and thus the ipg was removed during the procedure and a new ipg was placed that would accommodate dual leads.
Additional Manufacturer Narrative
Patient was seen for multiple follow-up sessions and reprogrammings and there was no indication of any system or component failure or malfunction.The patient did not participate in a trial phase with nalu as there was an existing system in place and so the nalu system was placed in a similar position as the previous system.It is likely that the placement of the single lead was insufficient to cover the location of the patient's pain symptoms.

• 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: 22067395
• Report Number: 3015425075-2025-00160
• Device Sequence Number: 15793626
• Product Code: GZF
• UDI-Device Identifier: 00812537036144
• UDI-Public: (01)00812537036144(11)220201(17)250201
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/21/2025

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: 02/01/2025
• 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: 04/15/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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