MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	71020
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no indications of any system or component failure or malfunction.Assessment of the implanted device found that the placement of the ipg in an unstable location was a direct contributing factor for the component instability and migration.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower back pain.The system was placed in the lower back area with the leads targeting the cluneal nerve.On (b)(6) 2026, the patient was seen in the clinic for reprogramming and during the visit the patient reported some issues with maintaining consistent connectivity between the implantable pulse generator (ipg) and the external therapy discs.Troubleshooting steps were performed, including reprogramming, adjusting system settings, replacing external devices, and adjusting position of external devices; however, the issue persisted.Further assessment determined that the ipg had been placed within a skin fold, causing the device to be unstable and migrate beyond the recommended depth for optimal connectivity.On (b)(6) 2026, a surgical revision was performed to move the ipg to a new pocket location that was more superficial and in a more flat location.During the procedure the ipg sustained some handling damage and required replacement.The originally implanted leads were not moved and remain implanted and in use.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008
• 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: 24794497
• Report Number: 3015425075-2026-00042
• Device Sequence Number: 18564489
• Product Code: GZF
• UDI-Device Identifier: 00812537037691
• UDI-Public: (01)00812537037691(11)251021(17)281021(10)9459905
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• 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): 04/04/2026

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• 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