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

Model Number	71005
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's pain symptoms seem to have manifested after sustaining a fall.It is unclear how the nalu components were affected by that fall as the xray imaging did not show any clear issues with migration or fractures of the internal components.Patient reported that the original nerve pain that nalu was treating remains present but is not as intense when the nalu system is active.It is suspected that the patient's pain symptoms are directly related to external trauma that adversely affected the implanted components.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat lower back pain.The implantable pulse generator (ipg) was implanted in the lower back area with 2 leads implanted on the right side of the back.Immediately after activation of the system, the patient reported pain symptoms decreased from (b)(6) down to (b)(6).At some point in 2024 the patient sustained a fall and was evaluated in a local emergency department, date is unknown.After the fall the patient noted that there was intense pain symptoms while the nalu system was activated.Troubleshooting was able to isolate the symptoms to one of the nalu leads and that lead was removed from programming.The patient continued to use the stimulator with a single lead for approximately one month before then reporting return of the pain symptoms while using the stimulator.Patient ceased using the nalu system completely due to the increased pain while using it, even with very low levels of stimulation.Xray imaging was done and was not conclusive in identifying the cause of the pain symptoms.On (b)(6) 2025 a full system explant took place.

• 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: 21724462
• Report Number: 3015425075-2025-00094
• Device Sequence Number: 18514458
• Product Code: GZF
• UDI-Device Identifier: 00812537036137
• UDI-Public: (01)00812537036137(11)231025(17)261025
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 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): 03/26/2025

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: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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