MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number	71005
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Migration occurred within approximately 2 weeks after implant.The circumstances leading to migration of the implanted component were not shared with the firm.Migration is a known inherent risk of implantable neuromodulation devices and there is insufficient information available to the firm to identify any other contributing factors in this case.
Event or Problem Description
The patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2025 to treat lower back pain.On (b)(6) 2025 the patient was discovered to have the implantable pulse generator (ipg) migrated from the original implanted position.A surgical procedure was scheduled to correct the position of the ipg; however, the procedure was not able to be completed.No further updates were provided to the firm regarding plan of care for this patient until a follow-up was performed on (b)(6) 2025 and the firm became aware that the nalu system had been fully explanted on an unknown date and replaced with a competitor system.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• 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: 23797649
• Report Number: 3015425075-2025-00346
• Device Sequence Number: 13375136
• Product Code: GZB
• UDI-Device Identifier: 00812537037189
• UDI-Public: (01)00812537037189(11)240716(17)270716
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 12/13/2025

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: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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