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

Model Number	71004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At each programming and education the patient reported feeling stimulation, seeming to indicate that the nalu system was functioning as intended.Patient reported feeling stimulation at the intended nerve target, seeming to indicate that there was no device migration.The patient reported feeling the pain symptoms regardless if the nalu system was active or turned off, as well as feeling pain symptoms in new locations that were not related to the area where the nalu system was treating and not related to the area where the nalu device was implanted.The location of the pain symptoms and the sensation of pain with the nalu device being completely turned off seems to indicate that the symptoms were not likely related to the nalu device.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat lower back pain.The system was activated on (b)(6) 2024 the patient notified a nalu representative of new onset of pain symptoms in the lower back area.Per the patient, symptoms began on the date of implant and persisted regardless of if the nalu system was turned on or not.Reprogramming of the nalu system was performed on (b)(6) 2024 and the patient indicated that an explant would be planned for (b)(6) 2024 due to the new pain symptoms.On (b)(6) 2024 the patient notified the medical facility that he would not be moving forward with the planned explant and would allow for post-surgical healing and further programming and troubleshooting with nalu before making any plans for further interventions.Patient was seen several times for education on the system and adjustment of programming.Patient reported a new onset of pain symptoms on the front of the hip and leg as well as ongoing pain in the lower back and back of the leg.Patient communicated several times with the local nalu representative that requests were made for the medical clinic to add or increase pain medication after the nalu implant and patient was dissatisfied that the clinic was not perceived as being cooperative in accomodating the patient's medication requests.On (b)(6) 2024 a full system explant was performed to remove the nalu system per the patient's request and due to ongoing various pain symptoms, that did not appear to be resolved with use of the nalu system.

• 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: 20767582
• Report Number: 3015425075-2024-00436
• Device Sequence Number: 15551943
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: 01008125370361201123080917260809
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 11/23/2024

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: 08/09/2026
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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