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

Model Number	71004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2023 to treat lower arm pain.The patient participated in a successful trial with nalu and reported pain reduction with the trial system.The permanent implantable pulse generator (ipg) was placed in the lower back area with the leads targeting the cervical nerve at the t5 vicinity.The system was successfully activated and aproximately one week after activation the patient reported having experienced a seizure.Patient perception was that the seizure may have somehow been related to the nalu implant despite having no prior issues with the trial system or at the time of the system activation.Patient declined to use the system moving forward and requested to have it explanted.A full system explant was performed on (b)(6) 2024 per the patient's request.
Additional Manufacturer Narrative
The physician verbalized to nalu personnel that there does not appear to be any correlation between the patient's medical condition and the nalu device.The seizure was unrelated to nalu, however the patient's spouse was adamant on removal of all implants after the seizure.

• 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: 21136643
• Report Number: 3015425075-2025-00020
• Device Sequence Number: 20540427
• Product Code: GZB
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)230505(17)260505
• 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: 2023
• Device Explanted Year: 2024
• 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): 01/11/2025

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: 05/05/2026
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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