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

Model Number	72001
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nalu team was not aware of any issues until the clinic visit in (b)(6) 2026 and onset date of symptoms was not shared.During the revision procedure, the nalu representative present observed that the skin erosion took place at the location where the excess lead coil was placed and the coil had been placed relatively superficial.There are no reports of any general issues with skin or tissue health at the implant site and no reports of any signs of infection at the erosion site.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat neck pain.At the time of implant the implantable pulse generator (ipg) was placed in the posterior shoulder area with the leads targeting the cervical nerve.During a follow-up clinic visit in (b)(6) 2026, a nalu representative was made aware that one of the implanted leads had eroded through the skin and a revision was being scheduled.On (b)(6) 2026 a surgical procedure was performed to reposition the existing lead deeper beneath the skin surface.No components were removed or replaced during the procedure and all original components remain implanted and in use.

• 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: 24794495
• Report Number: 3015425075-2026-00048
• Device Sequence Number: 9690232
• Product Code: GZF
• UDI-Device Identifier: 00812537037202
• UDI-Public: (01)00812537037202(11)250710(17)280710(10)9459456
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/04/2026

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
• Device Model Number: 72001
• Device Catalogue Number: 72001
• Device Lot Number: 9459456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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