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

Model Number	72006
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial complaints of patient dissatisfaction with the nalu system appear to be related to the patient condition or perception rather than any failure or malfunction of the system itself as all testing of the system while implanted indicated the device was functioning as expected and delivering stimulation to the appropriate location.The firm attempted to improve the patient's experience but was unable to complete any improvements due to patient's lack of cooperation.There was approximately 5 months between the initial implant procedure and the attempted explant procedure.The explanting physician noted that there was scar tissue formed around the tined end of the lead and the physician was not comfortable removing the scarred in component.There are no reports that the nalu device fractured or malfunctioned, however the physician decision to abandon the lead caused the patient to undergo additional invasive procedures.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower back pain after having completed a successful trial phase with nalu.In (b)(6) 2025 the patient expressed to a nalu representative that the system was not providing the level of pain relief expected and the patient was frustrated with the percieved limitations of the system in general.An appointment was arranged for the system to be evaluated and possible reprogramming to optimize therapy.During the session the nalu representative present confirmed good communication was achieved between all components and stimulation appeared to be received at the appropriate location being treated.Reprogramming was initiated but the patient again expressed frustration and the appointment was ended prematurely by the patient without having completed the reprogramming process.A system explant was performed on (b)(6) 2025 per the patient's request (see mdr 3015425075-2025-00246).During the explant procedure on (b)(6) 2025, the physician was unable to comfortably remove the implanted lead and elected to cut the lead, leaving the distal end fragment implanted.On (b)(6) 2025 the firm was notified that the patient required additional surgical intervention to remove the abandoned lead fragment so that an mri scan could be performed.The additional procedure took place on (b)(6) 2025 and removed the remaining nalu lead.

• 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: 22989074
• Report Number: 3015425075-2025-00269
• Device Sequence Number: 9257513
• Product Code: GZF
• UDI-Device Identifier: 00812537037370
• UDI-Public: (01)00812537037370(11)241126(17)271126(10)9458271
• 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
• 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): 09/06/2025

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: 9458271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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