MAUDE Adverse Event Report: Nalu Medical, Inc Nalu Neurostimulation System; Peripheral Nerve Stimulator

Model Number	71004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A nalu representative reported that during a patient follow-up visit at the medical clinic, the patient presented with a wound over previously intact skin.The wound is confirmed to be over the implantable pulse generator (ipg) pocket location and not at a surgical incision site, however the ipg is not visible at the surface wound location.\ the patient had been implanted with the nalu system and the surgical sites appeared to be healing well with no indication of any skin breakdown.After using the system for some time the patient reports having developed a small, scabby type spot.Per the patient, each time the adhesive clips were removed it would pull off bits of scab and skin and led to the wound growing larger.The patient did not report the wound and continued to use the nalu adhesive clips as there was good therapy being received from the system.\ the nalu system was explanted to promote healing.
Additional Manufacturer Narrative
The explanted device has been returned, and the evaluation is in process.A follow up will be sent once the evaluation is complete.\ per patient admission, the skin breakdown was not immediately reported and the patient continued to use adhesive clips over the compromised skin.Device history records were reviewed for all nalu components and found no deviations or nonconformances around the sterilization process.Physician consult concluded that the development of skin breakdown is likely multifactoral and a specific cause is unable to be identified.

• 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 -724
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008--724
• MDR Report Key: 50744645
• Report Number: 3015425075-2026-00090
• Device Sequence Number: 8862086
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)260202(17)290202
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 71004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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