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

Model Number	71005
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2024 to treat lower back pain.Patient had participated in a successful trial phase with nalu in which the patient reported reduction in pain levels from 8/10 down to 2/10.Shortly after activating the permanent system the patient began to experience issues with communication between the implantable pulse generator (ipg) and the external therapy discs.Troubleshooting found that the ipg had migrated within the pocket and was seated so that it was no longer parallel to the skin surface, causing the communication issues.On (b)(6) 2025, a surgical procedure was performed to reposition the existing ipg so that it is in the proper position for optimal communication with external components.No components were removed or replaced during the procedure and no new components were introduced.
Additional Manufacturer Narrative
There are no indications of any system or component failure and all original implanted components remain implanted and in use.The migration of the ipg occurred almost immediately after implanting the system.There are no reported events that took place after the implant that may have caused or contributed to the component movement.Migration is a known inherent risk of implantable neuromodulation systems.

• 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: 21417218
• Report Number: 3015425075-2025-00058
• Device Sequence Number: 12730516
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: (01)00812537036137(11)230815(17)260815
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 02/14/2025

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: 08/15/2026
• 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: 01/17/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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