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	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the initial implant, the physician used anchors to attach the leads to deep facia and there are no reports of any issues with tissue quality or instability at the implant site.There are no reported events reported that are likely to have led to migration of the implanted lead.Although the permanent system leads were reported to have been placed in the same location as the trial leads, the physician declined to perform intra-operative testing at the time of the procedure to assure stimulation was felt in the desired location.All of the original implant components remain implanted and in use after repositioning as there are no indications of any system or component failure beyond migration of the leads.
Event or Problem Description
The patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2025 after participating in a successful trial phase with nalu.The permanent system was implanted with the leads in approximately the same location as the trial leads.Although the patient had reported approximately 90% pain reduction during the trial phase, the permanent system was reported to have provided no pain relief at all.Troubleshooting in the field included 5 different sessions of reprogramming the system to optimize therapy, with ongoing reports of no pain relief.Xray imaging was performed and confirmed that the leads had migrated down a vertebral level, thus were no longer stimulating the area of the patient's pain symptoms.On (b)(6) 2025 a surgical procedure was performed to reposition the implanted leads and place an anchor to hold the leads in place.

• 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: 23375769
• Report Number: 3015425075-2025-00303
• Device Sequence Number: 18414795
• Product Code: GZB
• UDI-Device Identifier: 00812537037189
• UDI-Public: (01)00812537037189(11)241028(17)271028
• 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
• 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): 10/22/2025

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: 10/07/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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