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

Model Number	72006
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the initial implant procedure the physician declined to perform any intra-op testing of the system to confirm placement and function, despite recomendations from nalu personnel present at the procedure.As no testing was done at the time of implant, it is unable to be determined if the leads were malpositioned initially or if they migrated after implant.There is no indication of any system or component failure or malfunction as the patient reported feeling stimulation from the system at activation and during programming sessions.Unable to draw any conclusive determination regarding the placement and / or migration of the system with the information available.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat lower leg pain.Upon initial activation of the system the patient reported feeling stimulation but the therapy did not reach all the way down into the lower leg and foot area, which was the primary pain location.The system was reprogrammed several times in attempt to improve therapy.Physician determined that the implanted lead was not in the appropriate location to address the patient's pain and would need to be repositioned or revised.The medical facility where the patient was implanted gave the option to have the existing system repositioned or explanted only.The facility policy does not allow for any component replacement.On (b)(6) 2024 a surgical procedure was initiated to reposition the existing implanted lead to better address the applicable nerve target.During the procedure the physician was unable to successfully reposition the lead and ultimately fractured the lead.The implantable pulse generator (ipg), one full lead, and the proximal end of the second lead were explanted during the procedure.The distal end of the fractured lead was unable to be removed and there are no plans currently to perform any additional procedures to retrieve the fragment.

• 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: 21076237
• Report Number: 3015425075-2025-00012
• Device Sequence Number: 20929155
• Product Code: GZF
• UDI-Device Identifier: 00812537037370
• UDI-Public: (01)00812537037370(11)240626(17)270626(10)9457387
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/05/2025

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 Model Number: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 9457387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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