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

Model Number	72003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intent of trial procedures is to verify not only if the therapy is effective, but also to confirm approach and placement of the device.In this case, the patient's anatomy and tissue quality appears to have hindered the procedure.The physician suggested to the nalu representative present at the procedure that possibly the sharpness of the surgical tool may have played a role in the failed implant.The tools were discarded during the procedure and thus unavailable to the firm for inspection to confirm the condition of the spoonbill needle.
Event or Problem Description
On (b)(6)2025 the patient was prepped and anesthetized to implant a nalu trial system.The peripheral nerve stimulator trial was intended to treat lower arm pain by targetting the brachial plexus nerve.During the procedure, the spoonbill needle that was provided by nalu was inserted but the physician was unable to advance the needle without significant pressure due to the patient's thick tissue and vascular structures in the area of insertions.After unsuccessful attempts to advance the spoonbill needle, the physician reported being uncomfortable proceeding and the procedure was aborted.The physician noted that there was no other approach he was comfortable with due to the patient's anatomy and the desired nerve target.The patient was discharged with no adverse reactions after the unsuccessful trial procedure.

• 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: 21157956
• Report Number: 3015425075-2025-00025
• Device Sequence Number: 7656348
• Product Code: GZF
• UDI-Device Identifier: 00812537033631
• UDI-Public: (01)00812537033631(11)240307(17)270307(10)9456853
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/15/2025

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: 72003
• Device Catalogue Number: 72003
• Device Lot Number: 9456853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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