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	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had initially reported good therapy from the nalu system and later reported inadequate pain relief.Imaging was performed and showed no evidence of any component movement, with implanted components remaining in their original implant location.While performing multiple re-programming sessions with the patient, there are no reports of any concers with the function of the nalu system or any of it's components.The patient reports no new falls or injuries, however an unrelated hip surgery was performed after implanting the nalu system and it is unclear how this procedure may have affected the patient's pain symptoms and if there was any affect to the nalu system or any of its components.The explanted ipg was not released by the medical facility and thus is unavailable for any further testing by the firm.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat back pain.Several months after activating the system the patient reported discomfort from overstimulation.The patient was seen multiple times for reprogramming over the subsequent year, however the patient continued to express dissatisfaction with therapy.On (b)(6) 2026 a system explant was attempted at the request of the patient.During the procedure the physician found that both leads had significant scarring and were unable to be removed despite hydrodisection being used to loosen the components.Both leads fractured and were thus left in place with instructions for the patient to seek surgical consult if they wish to remove the lead fragment in the future.The implantable pulse generator (ipg) was successfully removed.

• 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: 24683614
• Report Number: 3015425075-2026-00032
• Device Sequence Number: 15953647
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)240717(17)270717
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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): 03/20/2026

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: 02/19/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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