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	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nalu representative present at the revision on (b)(6) 2025 reports that the initial implant utilized sutures through a silicone ring to anchor the leads.The sutures tore through the silicone ring and the leads had migrated.Although the patient did not report any symptoms related to the lead migration specifically, it is suspected that the lead movement placed pressure on the ipg, leading to rotation of the ipg within the pocket and thus connectivity symptoms.During the revision the physician utilized an alternate suture technique to increase implant stability.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower back pain.Approximately 2-3 months after the implant the patient reported onset of connectivity issues between the implantable pulse generator (ipg) and the external therapy discs.It was determined that the ipg had migrated within the pocket to no longer be seated flat and parallel to the skin surface, causing the connectivity challenges.On (b)(6) 2025, the ipg was removed from the existing pocket on the right flank area and a new ipg was implanted in the left flank area.

• 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: 23739139
• Report Number: 3015425075-2025-00341
• Device Sequence Number: 21041650
• Product Code: GZB
• UDI-Device Identifier: 00812537037189
• UDI-Public: (01)00812537037189(11)241028(17)271028
• 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: 2025
• 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): 12/07/2025

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: 11/14/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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