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	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of records found no reports on file with the firm of any issues or complaints from this patient regarding effectivity of therapy.Imaging taken at the time of explant was reviewed by the a nalu representative in florida and compared with imaging taken at the time of implant.The comparison of the images found no evidence of any component migration, however it was confirmed that the placement of the leads at the time of implant may have been inadequate to cover the patient's pain location.
Event or Problem Description
The patient had been implanted with a nalu peripheral nerve stimulator system in (b)(6) in (b)(6) 2024 to treat back pain.In (b)(6) 2026 the firm was notified that the nalu system was scheduled for explant in (b)(6) in preparation for mri.The explanting physician noted ineffective therapy as well as mri conditionality as the reason for explant.The system was removed on (b)(6) 2026.

• 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: 24393124
• Report Number: 3015425075-2025-00381
• Device Sequence Number: 10257864
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)240305(17)270305
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 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): 02/19/2026

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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