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	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of any events leading up to the ipg migration and it is noted that the ipg appears to have migrated immediately after implant while the healing process was taking place.It is unknown with the limited information available if the patient's body habitus played a role in the instability of the ipg or if the implanting or anchoring techniques played a role in allowing device migration.There are no reports of any impedance issues being present at the time of implant and all intra-op testing was reported to be appropriate.Impedance issues developed at some point after the implant, possibly related to the ipg movement placing stress on the leads or lead connectors.
Event or Problem Description
The patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2024 targeting the thoracic nerve.The implantable pulse generator (ipg) was placed in the patient's lower back area.During the healing process, prior to the implanted components developing scar tissue, the patient noted inconsistent connectivity between the ipg and the external therapy discs and it was determined that the ipg had rotated within the pocket so that it was no longer flat and parallel to the skin surface.Troubleshooting was performed in the field to encourage the ipg to remain flat, however was not successful.Both leads later returned impedance errors in addition to the connectivity issues from the ipg migration.On (b)(6) 2025 a surgical revision was performed to place a new ipg in a new pocket location and both malfunctioning leads were replaced with new leads.

• 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: 23275742
• Report Number: 3015425075-2025-00296
• Device Sequence Number: 8718188
• Product Code: GZB
• UDI-Device Identifier: 00812537037189
• UDI-Public: (01)00812537037189(11)240716(17)270716
• 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: 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): 10/12/2025

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: 09/17/2025
• Initial Report FDA Received Date: 10/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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