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

Model Number	72007
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician confirmed that there is no infection at the site of the exposed lead.The patient did not report any specific events or traumas at the location of the exposed lead.The system had been implanted for more than 7 months with no complaints prior to this event.Cause of the lead eroding through the skin is unable to be determined with the information available.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat right side lower back pain.In (b)(6) 2025 the firm was notified that the physician suspected the site to be infected and planned to remove the system.On (b)(6) 2025 the patient was brought to the surgical site and the physician found that there were actually no signs of infection but that the implanted lead had eroded through the skin at one location.The physician was able to reposition the lead and sutur it to the fascia, then close the skin, no components were removed during the procedure and no new components were introduced.The nalu system remains implanted and in use at the time of reporting.

• 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: 22178973
• Report Number: 3015425075-2025-00182
• Device Sequence Number: 8697515
• Product Code: GZF
• UDI-Device Identifier: 00812537037387
• UDI-Public: (01)00812537037387(11)240326(17)270326(10)9456935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/05/2025

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: 72007
• Device Catalogue Number: 72007
• Device Lot Number: 9456935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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