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

Model Number	71020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat knee pain.On (b)(6) 2025 a surgical revision was performed to remove the non-tined system and place a new system with tined leads to provide improved stability after one of the original leads had migrated and caused a reduction of pain relief.See mdr 3015425075-2025-00313 after using the system for several months the patient reported that therapy was still not meeting expectations.The system was reprogrammed multiple times to attempt optimization of therapy with no success.Imaging and system testing returned no issues.The physician and nalu team were unable to identify any obvious cause for the lack of pain relief and thus a full system replacement was performed on (b)(6) 2026.The explanted system was not released by the facility for further investigation by nalu.
Additional Manufacturer Narrative
The patient participated in a trial phase with nalu and elected to move forward with a permanent system implant after completing the trial, and the permanent system is reported to have been placed in approximately the same location as the trial.The initial system was found to have migrated away from the intended nerve target and thus led to inadequate pain relief.When the patient again reported inadequate pain relief with the new system, additional imaging was done and ruled any migration as a cause.Testing of the system found all components to be functioning as expected with no errors.Reprogramming was unable to achieve the level of pain relief the patient was expecting.It is unclear from the information provided if the patient is displaying unrealistic expectations of the nalu system or possibly the device was placed such that it is continuing to not adequately address the pain symptoms.There is no evidence of any system or component failure or malfunction with the nalu device.

• 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: 24776529
• Report Number: 3015425075-2026-00038
• Device Sequence Number: 21313543
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)240423(17)270423
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/01/2026

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: 03/03/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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