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

Model Number	71005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Immune System Problem (4435)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2024 to treat lower back, hip, and pelvic pain after participating in a successful trial phase.During a follow-up on (b)(6) 2024 the patient reported that pain levels had decreased from 7/10 down to 3/10.Patient later reported onset of new pain symptoms at the location of the implantable pulse generator (ipg) and stimulation outside of the desired location.The ipg was found to have migrated over top of the spine, causing the discomfort.A surgical procedure was performed on (b)(6) 2024 to create a new pocket to reposition the existing ipg off the spinal column.During the procedure, the implanted leads were damaged and required replacement.The new leads were positioned back at the desired nerve target to restore therapy and the patient reported good pain relief from the system.See mdr 3015425075-2024-00282.After the initial implant and throughout the course of treatment, despite receiving pain relief from the nalu system, the patient noted a flareup of a pre-existing autoimmune disorder.The patient worked with their physicians to control the symptoms; however, it was ultimately suggested that having the nalu system implanted may be contributing to the exacerbation of the autoimmune disorder symptoms.A full system explant was performed on (b)(6) 2025.
Additional Manufacturer Narrative
The patient reported no issues with the nalu system and stated good relief of the area being treated.The revision procedure that took place in (b)(6) 2024 was determined to be related to the implanting technique in which the ipg pocket was likely too large and allowed for instability.The patient reported being disappointed that the system was being removed as it was providing pain relief.Explant was performed due to a suspicion of the system influencing a pre-existing condition.The specific diagnosis was not shared with the firm.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21730944
• Report Number: 3015425075-2025-00133
• Device Sequence Number: 8735406
• Product Code: GZB
• UDI-Device Identifier: 00812537033600
• UDI-Public: (01)00812537033600(11)230612(17)240611
• 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: 2024
• 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): 03/31/2025

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 Expiration Date: 06/11/2024
• 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: 03/21/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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