MAUDE Adverse Event Report: Nalu Medical, Inc Nalu Neurostimulation System; Spinal Cord Stimulator

Model Number	71005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2023, with the system being replaced in (b)(6) 2025.In (b)(6) 2026, after having used the system for more than a year and a half, the patient reached out to nalu product support to report description of "significant" shocking sensation that was felt only when the nalu system was active.Per the patient, the sensations began approximately end of (b)(6) 2025, 2 weeks after the system had been replaced.A local nalu representative met with the patient to assess and reprogram the system during the visit the symptoms reported did not occur, however the patient did note that the symptoms were inconsistent or random.Imaging was completed and found no obvious issues with the implanted components.As no clear cause of the shocking sensation was able to be identified, it was decided that the system would be replaced.On (b)(6) 2026 the ipg was removed and replaced, leaving the original leads in place.The explanted component was not released from the facility for further testing and inspection by nalu.
Additional Manufacturer Narrative
Patient reported in (b)(6) 2026 that shocking sensations had been felt for the prior 18 months, however review of records found no reports of any issues and no requests for any reprogramming or assessment of the system function.Imaging was done while the system was implanted and did not show any obvious damage or other issues with the system.The explanted component was not returned to the firm for assessment and testing and thus there is no further investigation able to be completed for this case.The patient reported sensation described to feel like an electric shock, however the symptoms were not experienced when in the presence of a nalu employee and were unable to be further assessed to confirm if there was any potential injury or physical activity or behavior associated with the sensation.

• 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 -724
• Manufacturer (Section G): Nalu Medical, Inc; 2320 faraday ave; suite 100; carlsbad CA 92008 -724
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008
• MDR Report Key: 50024263
• Report Number: 3015425075-2026-00062
• Device Sequence Number: 21270233
• Product Code: GZB
• UDI-Device Identifier: 00812537037189
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2026

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: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 04/18/2024
• 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