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

Model Number	71019
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Inadequate Pain Relief (2388)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although imaging was used during the implant procedure and placement of the leads was confirmed, the leads were implanted in a very superficial area with limited fascia to suture the leads in place.Due to tissue quality and suturing, the leads were unstable and migrated immediately after implant.Lack of efficacy was noted immediately upon activating the system and was unable to be corrected through several troubleshooting and reprogramming attempts.Additionally, the ipg was placed in an area of pain, and the discomfort was unable to be fully resolved due to ineffective therapy from the migrated leads.Ultimately the patient elected to remove the system rather than repositioning due to the discomfort and lack of effective therapy.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to pain symptoms in the chest area and extending into the armpit area.The implantable pulse generator (ipg) was placed in the infraclavicular area with the leads targeting bilateral supraclavicular nerves.Both fluoroscopy and ultrasound were used during the implant procedure to assure appropriate placement.After implanting the system, the patient reported discomfort at the site of the ipg.The patient also experienced ineffective therapy due to migration of the implanted leads.In (b)(6) 2025, the firm was notified that the patient had elected to completely remove the system due to the discomfort and lack of pain relief.On approximately (b)(6) 2025 the firm was notified that the explant had taken place on (b)(6) 2025.No notification was received of the scheduled procedure and thus no representative of the firm was able to be present.The explanted device was not retained for return to nalu.

• 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: 22723533
• Report Number: 3015425075-2025-00236
• Device Sequence Number: 8884441
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)240202(17)270202
• 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: 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): 08/05/2025

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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