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	05/22/2025
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 and lower extremity pain.The implantable pulse generator (ipg) was initially placed in the left flank area, with the leads targeting the thoracic nerve.After implanting the system, the patient sustained a fall which caused the ipg to migrate to a position directly over the spine.After the fall the patient noted issues with communication between the ipg and the external therapy discs, as well as discomfort at the location of the ipg.Testing of the system showed the system continued to function as expected after migration, indicating no damage to the implanted components.On (b)(6) 2025 a surgical revision was performed to move the migrated ipg to the right flank area to correct the communication issues and alleviate patient discomfort.No components were removed or replaced during the procedure and no new components were implanted.See mdr 3015425075-2025-00092.After the revision was performed, intra-op and post-op testing found the system to be functioning as expected and the patient proceded to use the system for approximately one month before reporting new issues with connectivity between the ipg and the external therapy discs.Troubleshooting was performed, including replacement of the external therapy discs, however communication was not able to be established.On (b)(6) 2025 a surgical revision was performed to replace the ipg.
Additional Manufacturer Narrative
There was no indication of any system or component failure at the time of the revision procedure in (b)(6)2025, and all originally implanted components remained implanted and in use.Migration is a known inherent risk of implantable neuromodulation systems; however, this case appears to be directly related to a patient fall.The patient did not report any additional falls, injuries, or other events that took place within the month after repositioning the system.Troubleshooting was performed with nalu product support and engineering support while the ipg was still implanted and was unable to identify any cause for the communication issues.The device was requested to be returned for investigation but was not retained at the time of explant and is not available for any further testing.

• 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: 22768327
• Report Number: 3015425075-2025-00241
• Device Sequence Number: 9585505
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: (01)00812537036137(11)240111(17)270111
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/10/2025

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: 05/27/2025
• Initial Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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