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

Model Number	72011
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6)2023 after a successful trial phase with nalu.The patient had reported good pain relief during the trial and then reported less efficacy with the permanent system.There was no evidence of any system or component failure or migration.Physician reported that the placement of the lead was not optimal to achieve the desired coverage.On (b)(6)2024 a surgical procedure was performed to reposition the existing lead on the right side only to place the lead more medial and achieve better pain relief coverage for the patient.No components were removed or introduced during the procedure and all original implanted components remain in place and in use.
Additional Manufacturer Narrative
The lack of pain relief was noted immediately upon activating the permanent nalu system.The implanting physician verbalized that the original placement of the implanted lead was not optimal.There is no indication of any device failure or malfunction.Repositioning was done due to malposition of the implanted components.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21075704
• Report Number: 3015425075-2025-00006
• Device Sequence Number: 15564554
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: (01)00812537035628(11)220408(17)250408(10)QJ133
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/04/2025

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: 04/08/2025
• Device Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: QJ133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 01/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2022
• 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