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

Model Number	71019
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of any signs of migration and no reports of any events leading up to the reports of inadequate pain relief.It is unclear if the patient had good therapy imemdiately following the initial revision and then therapy changed, or if there was a lack of therapy immediately following the initial revision, however all field assessment points to malposition of the lead at the time of implant.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023.After healing from the procedure, it was noted that the implanted lead was very superficial under the skin.On (b)(6) 2024 a surgical intervention was performed to reposition the lead.No components were removed or replaced during the procedure.See mdr 3015425075-2024-00121.Surgical intervention was performed to reposition the implanted lead only, there are no issues with any portion of the nalu system or its components failing or malfunctioning.During the subsequent 2 years, the patient relocated residence to a new area and was referred to a different physician to assess lack of stimulation at the left lead.Testing of the system found that the placement of the left lead was inappropriate for achieving paresthesia and was not providing therapy to the patient's pain location.On (b)(6) 2026 a second surgical revision was performed to remove the malpositioned left lead and place a new lead at a location to provide therapy for the patient.Prior to closing the case, the lead was confirmed to achieve paresthesia and both leads were tested for impedances, confirming the system was functioning as expected.

• 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: 24575605
• Report Number: 3015425075-2026-00031
• Device Sequence Number: 18449870
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)230710(17)260710
• 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: 2023
• Device Explanted Year: 2026
• 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): 03/11/2026

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
• Device Expiration Date: 07/10/2026
• Device Model Number: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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